Trial Outcomes & Findings for Use of Low Cost Prostheses to Improve Upper Extremity Function in Children With Cerebral Palsy (NCT NCT03122171)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

Week 8

Results posted on

2020-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Prosthesis 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 Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Prosthesis 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 Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prosthesis n=6 Participants 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).
Age, Continuous	15.8 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Prosthesis n=5 Participants 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).
Number of Participants With Clinically Significant Increase in Assisting Hand Assessment (AHA) Score	4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Prosthesis n=5 Participants 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).
Number of Participants With Increase in Pediatric Motor Ability Log (PMAL) Scores Post-Treatment	4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Prosthesis n=5 Participants 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).
Number of Participants With Increase in Melbourne Assessment 2 (MA2) Scores Range of Motion	4 Participants
Number of Participants With Increase in Melbourne Assessment 2 (MA2) Scores Accuracy of Reach and Placement	3 Participants
Number of Participants With Increase in Melbourne Assessment 2 (MA2) Scores Dexterity of Grasp	3 Participants
Number of Participants With Increase in Melbourne Assessment 2 (MA2) Scores Fluency of Movement	2 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Prosthesis n=5 Participants 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).
Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment Daily Activities	3 Participants
Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment School Activities	3 Participants
Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment Movement and Balance	3 Participants
Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment Pain and Hurt	2 Participants
Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment Fatigue	1 Participants
Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment Eating Activities	1 Participants
Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment Speech and Communication	1 Participants

Adverse Events

Prosthesis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alice Chu, MD

Rutgers-New Jersey Medical School

Phone: (973) 972-2076

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place