Effect of Video Game-assisted and BoNT-A Injection Therapy on Spasticity, Activity and Participation in CP Patients
Keywords
Abstract
Dates
| Last Verified: | 01/31/2020 |
| First Submitted: | 02/16/2020 |
| Estimated Enrollment Submitted: | 02/25/2020 |
| First Posted: | 02/27/2020 |
| Last Update Submitted: | 02/25/2020 |
| Last Update Posted: | 02/27/2020 |
| Actual Study Start Date: | 02/16/2020 |
| Estimated Primary Completion Date: | 02/28/2022 |
| Estimated Study Completion Date: | 02/28/2022 |
Condition or disease
Intervention/treatment
Drug: Adults with hemiplegic spastic cerebral palsy
Device: Adults with hemiplegic spastic cerebral palsy
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Other: Adults with hemiplegic spastic cerebral palsy Adults (> 18 years old) with hemiplegic spastic cerebral palsy, with reduced hand function and spasticity as prevalent finding under clinical examination. Also these patients can walk but have problems with balance. Participants' cognitive function does not limit them to perform video game training. | Drug: Adults with hemiplegic spastic cerebral palsy IncobotulinumtoxinA will be injected in upper extremities according to recommended guidelines. Two methods will be used in the study: auditive electromyography (EMG) and ultrasound guided injection technique. The decision process of which muscles to inject will be based on information obtained through examination of hand function, the presence of increased muscle tone during the clinical examination as well as a positive response from auditive EMG |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Adults with CP (>= 18 years) - Spastic CP with one upper extremity affected - Grasp function and ability to open and close the hand actively - "Spastic hand and arm" as a prevalent finding verified by clinical examination - Ability to walk Exclusion Criteria: - Musculoskeletal illnesses that affect limbs (e.g., arthrosis, rheumatoid arthritis and amputations). - BoNT-A treatment of upper limbs in the previous 6 months. - Orthopedic or neurosurgery procedures performed on the upper limbs in the last 12 months. - Wrist contracture that prevents patient to play video games - Severe cognitive deficits - Other neurological disorders and severe psychiatric illnesses - Active user of MCVG console at home |
Outcome
Primary Outcome Measures
1. Goal Attainment Scale score at baseline [Baseline]
2. Goal Attainment Scale score after video games therapy [3 months after baseline]
3. Goal Attainment Scale score 6 weeks after injection therapy with BoNT-A [4.5 months after baseline]
4. Goal Attainment Scale score 3 months after injection therapy with BoNT-A [6 months after baseline]
5. Goal Attainment Scale score at the end of follow up period [9 months after baseline]
Secondary Outcome Measures
1. Change from baseline Patient Specific Functional Scale score at project defined points of assesment [Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline]
2. Gross Motor Function Classification System [Baseline]
3. Manual Ability Classification System (MACS) [Baseline]
4. Change from baseline Hand Grip Dynamometer score at project defined points of assesment [Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline]
5. Zancolli Classification Hand Function [Baseline]
6. House Functional Classification System [Baseline]
7. Change from baseline Modified Ashworth Scales score at project defined points of assesment [Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline]
8. Change from baseline Range of Motion score at project defined points of assesment [Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline]
9. Change from baseline Numeric rating scale (0-10) of symptoms related to pain at 9 months [Baseline, 9 months after baseline]
10. WAIS-IV Coding (Wechsler Adult Intelligence Scale ) [Baseline]
11. Change from baseline Hopkins Symptoms Checklist 25 score at 9 months [Baseline, 9 months after baseline]
12. Change from baseline Action Research Arm Test (ARAT) score at project defined points of assesment [Baseline, 3 months after baseline, 4.5 months after baseline, 6 months after baseline, 9 months after baseline]
13. Change from baseline Mini-Balance Evaluation Systems Test score at project defined points of assesment [Baseline, 3 months after baseline, 4.5 months after baseline, 6 months after baseline, 9 months after baseline]
14. Change from baseline Fatigue Severity Scale (FSS) at 9 months [Baseline, 9 months after baseline]
15. Change from baseline EQ-5D-5L (EuroQol 5 Dimensions 5 Level) Health related quality of life score at 9 months [Baseline, 9 months after baseline]
