RehabTouch Home Therapy for Stroke Patients

• Sponsor: Flint Rehabilitation Devices, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03503617
• Collaborator: Rancho Research Institute, Inc. (Other)
• Enrollment: 27
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.9
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

We will investigate the efficacy of a newly developed exercise device (RehabTouch) for people in the subacute stage after a stroke compared to a traditional tabletop exercise program. RehabTouch uses embedded sensors that can track and record the patient's direction and degree of movement as they perform exercises described on a computer.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Stroke	Device: RehabTouch; Other: Conventional tabletop exercise program	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: RehabTouch: A Mixed-reality Gym for Rehabilitating the Hands, Arms, Trunk, and Legs After Stroke
• Actual Study Start Date: Nov 1, 2018
• Actual Primary Completion Date: Mar 31, 2021
• Actual Study Completion Date: Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RehabTouch Exercise Program Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks.	Device: RehabTouch; Exercise using the motion sensing devices and a computer; Other Names: FitMi
Active Comparator: Conventional tabletop exercise program Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks.	Other: Conventional tabletop exercise program; Exercise following printed sheets of exercises

Outcome Measures

Primary Outcome Measures

1. Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy [From Baseline to One-month Post-therapy]

   The Fugl-Meyer Arm Motor Score is a stroke-specific, performance-based impairment index which measure 33 arm movement patterns based on a scale of 0 to 2 each, for a total possible score of 66. For each movement patter, a score of zero means the participant is unable to perform the movement pattern; a score of 2 means the participant performed the movement patterns faultlessly.

Secondary Outcome Measures

1. Change in Box and Blocks Test Score [From Baseline to One-month Post-therapy]

   The Box & Blocks Test (BBT) score assess hand function and gripping ability by instructing an individual to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period.

2. 10 Meter Walk Test [From Baseline to One-month Post-therapy]

   The 10MWT assesses walking speed in meters per second over a short duration.

3. Motor Activity Log [One-month Post-therapy]

   The Motor Activity Log (MAL) is a semi-structured interview to assess arm function after hemiparetic stroke. Individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 28 daily functional tasks on a 0-5 point scale. For the QOM subscale, 0 represents an inability to use the affected arm to perform an activity, while 5 represents a normal ability to use the affected arm. For the AOM scale, 0 represents never using the affected arm to perform the activity, and 5 indicates always using the affected arm to perform the activity.

4. Visual Analog Pain Scale [From Baseline to One-month Post-therapy]

   A standard analog scale that ranges from 0 to 10 for assessing pain.

5. Modified Ashworth Spasticity Scale [From Baseline to One-month Post-therapy]

   The Modified Ashworth Spasticity (MAS) Scale measures spasticity in patients with lesions of the Central Nervous System. Tests resistance to passive movement about a joint with varying degrees of velocity, with movements in flexion and extension scored separately. Scores for each movement direction and joint range from 0-5, with 6 choices. A score of 0 indicates no increase in tone during movement. A score of 5 indicates that the limb was rigid during the passive movement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age: 18 to 85 years old

• Upper extremity weakness measured by a clinical scale

• Absence of moderate to severe pain on affected upper extremity

• Able to understand the instructions to operate RehabTouch

Exclusion Criteria:

• Concurrent severe medical problems, visual deficits, severe neglect or apraxia

• Enrollment to other therapy studies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rancho Research Institute, Inc.	Downey	California	United States	90242

Sponsors and Collaborators

• Flint Rehabilitation Devices, LLC
• Rancho Research Institute, Inc.

Investigators

• Principal Investigator: Susan Shaw, MD, Rancho Research Institute, Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 31, 2021

More Information

Publications

None provided.

• Responsible Party: Flint Rehabilitation Devices, LLC, Vice President, Flint Rehabilitation Devices, LLC
• ClinicalTrials.gov Identifier: NCT03503617
• Other Study ID Numbers: 1R44AG059256-01A1
• First Posted: Apr 20, 2018
• Last Update Posted: Feb 7, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

Arm/Group Title	RehabTouch Exercise Program	Conventional Tabletop Exercise Program
Arm/Group Description	Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer	Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises
Period Title: Overall Study
STARTED	14	13
COMPLETED	14	10
NOT COMPLETED	0	3

Baseline Characteristics

Arm/Group Title	RehabTouch Exercise Program	Conventional Tabletop Exercise Program	Total
Arm/Group Description	Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer	Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises	Total of all reporting groups
Overall Participants	14	13	27
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	50 (11)	52 (9)	52 (10)
Sex: Female, Male (Count of Participants)
Female	0 0%	4 30.8%	4 14.8%
Male	14 100%	9 69.2%	23 85.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	8 57.1%	10 76.9%	18 66.7%
Not Hispanic or Latino	6 42.9%	3 23.1%	9 33.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 14.3%	1 7.7%	3 11.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 7.1%	2 15.4%	3 11.1%
White	1 7.1%	2 15.4%	3 11.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	10 71.4%	8 61.5%	18 66.7%
Region of Enrollment (participants) [Number]
United States	14 100%	13 100%	27 100%

Outcome Measures

1. Primary Outcome

Title	Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy
Description	The Fugl-Meyer Arm Motor Score is a stroke-specific, performance-based impairment index which measure 33 arm movement patterns based on a scale of 0 to 2 each, for a total possible score of 66. For each movement patter, a score of zero means the participant is unable to perform the movement pattern; a score of 2 means the participant performed the movement patterns faultlessly.
Time Frame	From Baseline to One-month Post-therapy

Outcome Measure Data

Analysis Population Description

Three participants in the conventional therapy group did not perform their one-month follow-up assessment; one of these did perform the end-of-therapy assessment. For this one participant, the missing one-month follow-up data point was imputed for the primary outcome measure by adding the average change in Fugl-Meyer score across all participants in the conventional therapy group from end-of-therapy to one-month follow-up to this participant's end-of-therapy Fugl-Meyer score.

Arm/Group Title	RehabTouch Exercise Program	Conventional Tabletop Exercise Program
Arm/Group Description	Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer	Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises
Measure Participants	14	11
Mean (Standard Deviation) [Score on a Scale]	8.0 (4.6)	3.1 (6.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RehabTouch Exercise Program, Conventional Tabletop Exercise Program
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Change in Box and Blocks Test Score
Description	The Box & Blocks Test (BBT) score assess hand function and gripping ability by instructing an individual to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period.
Time Frame	From Baseline to One-month Post-therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RehabTouch Exercise Program	Conventional Tabletop Exercise Program
Arm/Group Description	Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer	Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises
Measure Participants	14	10
Mean (Standard Deviation) [Boxes]	31.1 (20.2)	27.1 (16.9)

3. Secondary Outcome

Title	10 Meter Walk Test
Description	The 10MWT assesses walking speed in meters per second over a short duration.
Time Frame	From Baseline to One-month Post-therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RehabTouch Exercise Program	Conventional Tabletop Exercise Program
Arm/Group Description	Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer	Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises
Measure Participants	14	10
Mean (Standard Deviation) [meters per second]	1.06 (0.41)	1.07 (0.39)

4. Secondary Outcome

Title	Motor Activity Log
Description	The Motor Activity Log (MAL) is a semi-structured interview to assess arm function after hemiparetic stroke. Individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 28 daily functional tasks on a 0-5 point scale. For the QOM subscale, 0 represents an inability to use the affected arm to perform an activity, while 5 represents a normal ability to use the affected arm. For the AOM scale, 0 represents never using the affected arm to perform the activity, and 5 indicates always using the affected arm to perform the activity.
Time Frame	One-month Post-therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RehabTouch Exercise Program	Conventional Tabletop Exercise Program
Arm/Group Description	Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer	Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises
Measure Participants	14	10
Amount of Use	3.11 (1.14)	2.72 (1.65)
How Well	3.01 (1.26)	2.50 (1.53)

5. Secondary Outcome

Title	Visual Analog Pain Scale
Description	A standard analog scale that ranges from 0 to 10 for assessing pain.
Time Frame	From Baseline to One-month Post-therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RehabTouch Exercise Program	Conventional Tabletop Exercise Program
Arm/Group Description	Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer	Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises
Measure Participants	14	10
Mean (Standard Deviation) [Score on a Scale]	2.5 (2.3)	4.6 (3.1)

6. Secondary Outcome

Title	Modified Ashworth Spasticity Scale
Description	The Modified Ashworth Spasticity (MAS) Scale measures spasticity in patients with lesions of the Central Nervous System. Tests resistance to passive movement about a joint with varying degrees of velocity, with movements in flexion and extension scored separately. Scores for each movement direction and joint range from 0-5, with 6 choices. A score of 0 indicates no increase in tone during movement. A score of 5 indicates that the limb was rigid during the passive movement.
Time Frame	From Baseline to One-month Post-therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RehabTouch Exercise Program	Conventional Tabletop Exercise Program
Arm/Group Description	Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer	Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises
Measure Participants	14	10
Extension	0.42 (0.7)	0.63 (0.92)
Flexion	2.5 (2.1)	2.1 (2.3)

Adverse Events

Time Frame	1 year, 4 months
Arm/Group Title	RehabTouch Exercise Program		Conventional Tabletop Exercise Program
Arm/Group Description	Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer		Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises
All Cause Mortality
	RehabTouch Exercise Program		Conventional Tabletop Exercise Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/13 (0%)
Serious Adverse Events
	RehabTouch Exercise Program		Conventional Tabletop Exercise Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	RehabTouch Exercise Program		Conventional Tabletop Exercise Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/13 (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.