Use of Low Cost Prostheses to Improve Upper Extremity Function in Children With Cerebral Palsy

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT03122171
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Actual Duration (Months): 33.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of the study is to assess the effectiveness of an upper extremity prosthesis in improving the upper extremity function of children with cerebral palsy who have limited use of their hands. Twelve children, aged 4-17 years, who have cerebral palsy and limitations in their ability to use their hands, will be enrolled. All participants will be fitted with a 3D printed arm/hand prosthesis and receive 8 occupational therapy sessions. Each subject will be evaluated pre-treatment, post-occupational therapy sessions and at 6 months follow-up. The evaluation will include assessment of (1)passive and active arm/hand movement and (2)functional hand skills using several standardized tests. The results from the pre-treatment and the two post-treatment evaluations will be compared.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy; Prosthesis User	Other: Occupational Therapy Treatment	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Use of Low Cost Prostheses to Improve Upper Extremity Function in Children With Cerebral Palsy
• Actual Study Start Date: Apr 1, 2017
• Actual Primary Completion Date: Jan 13, 2020
• Actual Study Completion Date: Jan 13, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prosthesis	Other: Occupational Therapy Treatment; Each occupational therapy treatment will be a one-hour standardized session that will include the following: stretching/strengthening (approximately 20 minutes), bi-manual training (approximately 20 minutes), and activities of daily living (approximately 20 minutes).

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Clinically Significant Increase in Assisting Hand Assessment (AHA) Score [Week 8]

   The Assisting Hand Assessment (AHA) is a test of hand function in children with difficulties using one of their hands. The AHA measures how effectively the affected hand and arm is used in bimanual performance. An assessment is performed by observing the child's spontaneous handling of toys in a relaxed and playful session. Scores based on 22-items on a 4-point rating scale evaluating quality of the performance (1=does not do, 4=effective). The range of sum scores is 22-88 points. A clinical significant increase in score indicates an increase in quality of performance.

2. Number of Participants With Increase in Pediatric Motor Ability Log (PMAL) Scores Post-Treatment [8 weeks]

   The PMAL is a structured interview in which the caregiver reports "How Often" (amount) and "How Well" (quality of movement) the child uses their involved upper limb when completing 22 activities of daily living. Scores range from 0-10; the higher the score, the better the quality of movement. An increase in PMAL score indicates a higher amount of upper extremity use and better quality of movement.

3. Number of Participants With Increase in Melbourne Assessment 2 (MA2) Scores [Week 8]

   The Melbourne Assessment 2 (MA2) is a valid and reliable criterion-referenced test for evaluating four elements of upper limb movement quality in children with a neurological impairment aged 2.5 to 15 years: (i) Range of motion, (ii) Accuracy of reach and placement, (iii) Dexterity of grasp, release and manipulation and (iv) Fluency of movement. An increase in score indicates an increase in upper limb movement quality.

Secondary Outcome Measures

1. Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment [8 weeks]

   The PedsQL is a brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of HRQOL in pediatric patients with chronic health conditions using pediatric cancer as an exemplary model. 7 sub-tests will be reported on. Higher scores indicate better HRQOL (Health-Related Quality of Life), an increase in score indicates an increase in HRQOL.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis: cerebral palsy

• 4-17 years old

• MACS levels III - V

• Active movement of wrist or elbow

Exclusion Criteria:

• MACS levels I, II

• Botox or orthopedic surgery in past 6 months

• Severe contractures

• Lack of voluntary arm motion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Alice Chu, MD, NYU Langone Health

Study Documents (Full-Text)

• Study Protocol - Feb 27, 2017

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03122171
• Other Study ID Numbers: 16-02093
• First Posted: Apr 20, 2017
• Last Update Posted: Nov 20, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Cerebral Palsy

Study Results

Participant Flow

Arm/Group Title	Prosthesis
Arm/Group Description	Occupational Therapy Treatment: Each occupational therapy treatment will be a one-hour standardized session that will include the following: stretching/strengthening (approximately 20 minutes), bi-manual training (approximately 20 minutes), and activities of daily living (approximately 20 minutes).
Period Title: Overall Study
STARTED	6
COMPLETED	5
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Prosthesis
Arm/Group Description	Occupational Therapy Treatment: Each occupational therapy treatment will be a one-hour standardized session that will include the following: stretching/strengthening (approximately 20 minutes), bi-manual training (approximately 20 minutes), and activities of daily living (approximately 20 minutes).
Overall Participants	6
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	15.8
Sex: Female, Male (Count of Participants)
Female	5 83.3%
Male	1 16.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	6 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Clinically Significant Increase in Assisting Hand Assessment (AHA) Score
Description	The Assisting Hand Assessment (AHA) is a test of hand function in children with difficulties using one of their hands. The AHA measures how effectively the affected hand and arm is used in bimanual performance. An assessment is performed by observing the child's spontaneous handling of toys in a relaxed and playful session. Scores based on 22-items on a 4-point rating scale evaluating quality of the performance (1=does not do, 4=effective). The range of sum scores is 22-88 points. A clinical significant increase in score indicates an increase in quality of performance.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prosthesis
Arm/Group Description	Occupational Therapy Treatment: Each occupational therapy treatment will be a one-hour standardized session that will include the following: stretching/strengthening (approximately 20 minutes), bi-manual training (approximately 20 minutes), and activities of daily living (approximately 20 minutes).
Measure Participants	5
Count of Participants [Participants]	4 66.7%

2. Primary Outcome

Title	Number of Participants With Increase in Pediatric Motor Ability Log (PMAL) Scores Post-Treatment
Description	The PMAL is a structured interview in which the caregiver reports "How Often" (amount) and "How Well" (quality of movement) the child uses their involved upper limb when completing 22 activities of daily living. Scores range from 0-10; the higher the score, the better the quality of movement. An increase in PMAL score indicates a higher amount of upper extremity use and better quality of movement.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prosthesis
Arm/Group Description	Occupational Therapy Treatment: Each occupational therapy treatment will be a one-hour standardized session that will include the following: stretching/strengthening (approximately 20 minutes), bi-manual training (approximately 20 minutes), and activities of daily living (approximately 20 minutes).
Measure Participants	5
Count of Participants [Participants]	4 66.7%

3. Primary Outcome

Title	Number of Participants With Increase in Melbourne Assessment 2 (MA2) Scores
Description	The Melbourne Assessment 2 (MA2) is a valid and reliable criterion-referenced test for evaluating four elements of upper limb movement quality in children with a neurological impairment aged 2.5 to 15 years: (i) Range of motion, (ii) Accuracy of reach and placement, (iii) Dexterity of grasp, release and manipulation and (iv) Fluency of movement. An increase in score indicates an increase in upper limb movement quality.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prosthesis
Arm/Group Description	Occupational Therapy Treatment: Each occupational therapy treatment will be a one-hour standardized session that will include the following: stretching/strengthening (approximately 20 minutes), bi-manual training (approximately 20 minutes), and activities of daily living (approximately 20 minutes).
Measure Participants	5
Range of Motion	4 66.7%
Accuracy of Reach and Placement	3 50%
Dexterity of Grasp	3 50%
Fluency of Movement	2 33.3%

4. Secondary Outcome

Title	Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment
Description	The PedsQL is a brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of HRQOL in pediatric patients with chronic health conditions using pediatric cancer as an exemplary model. 7 sub-tests will be reported on. Higher scores indicate better HRQOL (Health-Related Quality of Life), an increase in score indicates an increase in HRQOL.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prosthesis
Arm/Group Description	Occupational Therapy Treatment: Each occupational therapy treatment will be a one-hour standardized session that will include the following: stretching/strengthening (approximately 20 minutes), bi-manual training (approximately 20 minutes), and activities of daily living (approximately 20 minutes).
Measure Participants	5
Daily Activities	3 50%
School Activities	3 50%
Movement and Balance	3 50%
Pain and Hurt	2 33.3%
Fatigue	1 16.7%
Eating Activities	1 16.7%
Speech and Communication	1 16.7%

Adverse Events

Time Frame	8 weeks
Arm/Group Title	Prosthesis
Arm/Group Description	Occupational Therapy Treatment: Each occupational therapy treatment will be a one-hour standardized session that will include the following: stretching/strengthening (approximately 20 minutes), bi-manual training (approximately 20 minutes), and activities of daily living (approximately 20 minutes).
All Cause Mortality
	Prosthesis
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Serious Adverse Events
	Prosthesis
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Other (Not Including Serious) Adverse Events
	Prosthesis
	Affected / at Risk (%)	# Events
Total	0/6 (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.