Cerebral Palsy, Prosthesis User
Conditions
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.
Interventions
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).
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Prosthesis |
|---|---|
| Age, Continuous | 15.8 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Number of Participants With Clinically Significant Increase in Assisting Hand Assessment (AHA) Score
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prosthesis | Number of Participants With Clinically Significant Increase in Assisting Hand Assessment (AHA) Score | 4 Participants |
Primary
Number of Participants With Increase in Melbourne Assessment 2 (MA2) Scores
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prosthesis | Number of Participants With Increase in Melbourne Assessment 2 (MA2) Scores | Range of Motion | 4 Participants |
| Prosthesis | Number of Participants With Increase in Melbourne Assessment 2 (MA2) Scores | Accuracy of Reach and Placement | 3 Participants |
| Prosthesis | Number of Participants With Increase in Melbourne Assessment 2 (MA2) Scores | Dexterity of Grasp | 3 Participants |
| Prosthesis | Number of Participants With Increase in Melbourne Assessment 2 (MA2) Scores | Fluency of Movement | 2 Participants |
Primary
Number of Participants With Increase in Pediatric Motor Ability Log (PMAL) Scores Post-Treatment
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prosthesis | Number of Participants With Increase in Pediatric Motor Ability Log (PMAL) Scores Post-Treatment | 4 Participants |
Secondary
Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prosthesis | Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment | Daily Activities | 3 Participants |
| Prosthesis | Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment | School Activities | 3 Participants |
| Prosthesis | Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment | Movement and Balance | 3 Participants |
| Prosthesis | Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment | Pain and Hurt | 2 Participants |
| Prosthesis | Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment | Fatigue | 1 Participants |
| Prosthesis | Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment | Eating Activities | 1 Participants |
| Prosthesis | Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment | Speech and Communication | 1 Participants |