Robotic and Conventional Hand Therapy After Stroke

• Sponsor: Columbia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03020576
• Collaborator: Medical University Innsbruck (Other), New York University (Other)
• Enrollment: 31
• Locations: 2
• Arms: 2
• Duration (Months): 59
• Patients Per Site: 15.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Weakness is a major cause of disability in stroke survivors. Rehabilitation techniques are often not effective in restoring full function of the upper limb. Specifically, many individuals remain with weakness in the hand, preventing its return to full use.

Robotic therapies have been developed as exercise tools for stroke survivors. Devices, such as the InMotion2, have been shown to be useful in restoring some motor function in the upper limb. However, most existing devices designed to be used with the upper limb have primarily been developed to treat the shoulder, elbow and wrist. They have not specifically addressed hand function.

Tyromotion, Inc. has developed the Amadeo, which is primarily intended to provide rehabilitation for patients with neurological or orthopedic deficits in hand function. Initial clinical testing has demonstrated the practicality of using this device in a population of stroke survivors, although further research is needed to better understand the usefulness of the Amadeo device as compared with conventional rehabilitation methods. The purpose of this study was to compare results of training with the Amadeo device or training with conventional therapies.

A total of 28 subjects from two separate sites participated in the study and underwent baseline testing of upper limb motor and sensory performance and function. Subjects were then assigned to one of two treatment groups with a 50:50 chance of being in either group. One group underwent training with the Amadeo device and the other group underwent training with conventional therapy. All training sessions were 60 minutes in duration, three days/week for eight weeks (24 total sessions). Subjects were reassessed on completion of the training program.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Amadeo Hand Robot Device; Other: Conventional Therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Robot-assisted Hand Training (Amadeo) Compared With Conventional Physiotherapy Techniques in Chronic Ischemic Stroke Patients: A Pilot Study
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional Therapy Participants randomized to this arm will receive conventional based therapy to their affected upper limb dose matched with the Robotic Therapy group. These interventions are aimed at increasing range of motion, strength and function at the shoulder, elbow, wrist and hand.	Other: Conventional Therapy; This arm involves treatment using conventional methods designed to promote range of motion, strength, coordination and function at the level of the shoulder, elbow, wrist and hand.
Experimental: Robotic Therapy Participants randomized to this arm will receive robotic based therapy using the Amadeo Hand Robot device to improve range of motion, strength, and coordination to the wrist and hand.	Device: Amadeo Hand Robot Device; This is a robotic device designed to offer rehabilitation to remediate weakness and limitations of range of motion of the hand and fingers.

Outcome Measures

Primary Outcome Measures

1. Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer [Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point)]

   quantitative performance measure (scale ranging from 0 (minimum) to 66 (maximum) points) of arm and hand impairment. A higher score represents more skilled movements of the arm and hand.

Secondary Outcome Measures

1. Change in Range of Motion Measures [Through study completion, an average of 8 weeks]

   quantitative assessment of the mobility of joints throughout the upper limb using standard goniometric measures. Measured in degrees (0-360 degrees)

2. Change in Hand and Pinch Strength [Through study completion, an average of 8 weeks]

   quantitative assessment of hand strength using standard dynamometry measurements in units of kilograms

3. Change in Motor Activity Log Amount [Through study completion (taken at baseline and at 8-week study completion)]

   quantitative, self report scale measuring the 'Amount' and 'How Well' an individual performs a battery of motor tasks. Maximum score of 150 (raw score) for each 'Amount' and 'How Well' sections. Higher scores reflect better performance.

4. Change in Mobility and Activities of Daily Living [Through study completion (taken at baseline and at 8 week study completion)]

   The Barthel Index is a quantitative scale measuring the need for assistance an individual has in performance of tasks of general mobility and activities of daily living. Maximum raw score is 100. Higher values represent better outcomes.

5. Change in Hand Dexterity [Through study completion, an average of 8 weeks]

   The 9 Hole Peg Test was used as a quantitative measure of hand dexterity. The participant is asked to remove the pegs and put them back into the slots in a period of 100 sec. The number of pegs moved is recorded as an overall score.

6. Change in Spasticity Measures [Through study completion, an average of 8 weeks]

   The Modified Ashworth Scale is a standardized quantitative assessment of muscle tightness/spasticity during movements of the arm and wrist. It is scored on a scale of 1-5, with higher numbers reflecting a greater severity of spasticity.

7. Change in Motor Activity Log How Well [Through study completion (taken at baseline and on 8 week study completion)]

   quantitative, self report scale measuring the 'Amount' and 'How Well' an individual performs a battery of motor tasks. Maximum score of 150 (raw score) for each 'Amount' and 'How Well' sections. Higher scores reflect better performance.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• history of stroke (>3 months from time of ictus)

• paresis or plegia of the upper extremity.

Exclusion Criteria:

• severe spasticity (defined on the Ashworth Scale with a score of 4-5)

• severe pain despite conventional pain therapy of the paretic upper extremity

• swelling, infection, fracture or ulcers of the paretic extremity

• arthritis of the hand joints

• pregnant

• botulinum toxin- therapy to the upper extremity within 3 months prior to study entry

• severe contractions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Medical Center	New York	New York	United States	10032
2	Innsbruck Medical University	Innsbruck		Austria	6020

Sponsors and Collaborators

• Columbia University
• Medical University Innsbruck
• New York University

Investigators

• Principal Investigator: Joel Stein, MD, Columbia University
• Principal Investigator: Raimund Helbok, MD, Innsbruck Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joel Stein, Department of Rehabilitation and Regenerative Medicine Chair, Columbia University
• ClinicalTrials.gov Identifier: NCT03020576
• Other Study ID Numbers: AAAI0093
• First Posted: Jan 13, 2017
• Last Update Posted: Jan 25, 2018
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

Arm/Group Title	Conventional Group	Robotic Group
Arm/Group Description	The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.	The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
Period Title: Overall Study
STARTED	15	16
COMPLETED	14	14
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Conventional Group	Robotic Group	Total
Arm/Group Description	The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.	The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.	Total of all reporting groups
Overall Participants	14	14	28
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.14 (17.9)	54.57 (13.8)	57.13 (15.10)
Sex: Female, Male (Count of Participants)
Female	3 21.4%	7 50%	10 35.7%
Male	11 78.6%	7 50%	18 64.3%
Region of Enrollment (Count of Participants)
Austria	10 71.4%	6 42.9%	16 57.1%
United States	4 28.6%	8 57.1%	12 42.9%

Outcome Measures

1. Primary Outcome

Title	Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer
Description	quantitative performance measure (scale ranging from 0 (minimum) to 66 (maximum) points) of arm and hand impairment. A higher score represents more skilled movements of the arm and hand.
Time Frame	Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Group	Robotic Group
Arm/Group Description	The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.	The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
Measure Participants	14	14
Mean (Standard Deviation) [change in units on a scale]	5.9 (13.7)	2.1 (16.3)

2. Secondary Outcome

Title	Change in Range of Motion Measures
Description	quantitative assessment of the mobility of joints throughout the upper limb using standard goniometric measures. Measured in degrees (0-360 degrees)
Time Frame	Through study completion, an average of 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Group	Robotic Group
Arm/Group Description	The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.	The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
Measure Participants	14	14
Mean (Standard Deviation) [change in units on a scale]	3.53 (0.45)	3.33 (0.80)

3. Secondary Outcome

Title	Change in Hand and Pinch Strength
Description	quantitative assessment of hand strength using standard dynamometry measurements in units of kilograms
Time Frame	Through study completion, an average of 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Group	Robotic Group
Arm/Group Description	The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.	The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
Measure Participants	14	14
Mean (Standard Deviation) [change in kilograms]	1.63 (7.8)	0.84 (5.3)

4. Secondary Outcome

Title	Change in Motor Activity Log Amount
Description	quantitative, self report scale measuring the 'Amount' and 'How Well' an individual performs a battery of motor tasks. Maximum score of 150 (raw score) for each 'Amount' and 'How Well' sections. Higher scores reflect better performance.
Time Frame	Through study completion (taken at baseline and at 8-week study completion)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Group	Robotic Group
Arm/Group Description	The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.	The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
Measure Participants	14	14
Mean (Standard Deviation) [units on a scale]	9.35 (35.1)	2.53 (37.7)

5. Secondary Outcome

Title	Change in Mobility and Activities of Daily Living
Description	The Barthel Index is a quantitative scale measuring the need for assistance an individual has in performance of tasks of general mobility and activities of daily living. Maximum raw score is 100. Higher values represent better outcomes.
Time Frame	Through study completion (taken at baseline and at 8 week study completion)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Group	Robotic Group
Arm/Group Description	The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.	The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
Measure Participants	14	14
Mean (Standard Deviation) [units on a scale]	6.78 (19.1)	-0.36 (12.3)

6. Secondary Outcome

Title	Change in Hand Dexterity
Description	The 9 Hole Peg Test was used as a quantitative measure of hand dexterity. The participant is asked to remove the pegs and put them back into the slots in a period of 100 sec. The number of pegs moved is recorded as an overall score.
Time Frame	Through study completion, an average of 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Group	Robotic Group
Arm/Group Description	The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.	The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
Measure Participants	14	14
Mean (Standard Deviation) [units on a scale]	10.67 (47.8)	-1.12 (24.3)

7. Secondary Outcome

Title	Change in Spasticity Measures
Description	The Modified Ashworth Scale is a standardized quantitative assessment of muscle tightness/spasticity during movements of the arm and wrist. It is scored on a scale of 1-5, with higher numbers reflecting a greater severity of spasticity.
Time Frame	Through study completion, an average of 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Group	Robotic Group
Arm/Group Description	The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.	The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
Measure Participants	14	14
Mean (Standard Deviation) [change in units on a scale]	-0.10 (0.3)	-0.10 (0.2)

8. Secondary Outcome

Title	Change in Motor Activity Log How Well
Description	quantitative, self report scale measuring the 'Amount' and 'How Well' an individual performs a battery of motor tasks. Maximum score of 150 (raw score) for each 'Amount' and 'How Well' sections. Higher scores reflect better performance.
Time Frame	Through study completion (taken at baseline and on 8 week study completion)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Group	Robotic Group
Arm/Group Description	The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.	The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
Measure Participants	14	14
Mean (Standard Deviation) [units on a scale]	12.79 (29.5)	2.6 (35.4)

Adverse Events

Arm/Group Title	Conventional Group		Robotic Group
Arm/Group Description	The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.		The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
All Cause Mortality
	Conventional Group		Robotic Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Conventional Group		Robotic Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Conventional Group		Robotic Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.