Effect of Video Game-assisted and BoNT-A Injection Therapy on Spasticity, Activity and Participation in CP Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cerebral Palsy, Spastic
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: The single subject design was chosen due to its sensitivity to individual differences which is a relevant feature when studying heterogenous population as adults with spastic CP. The study is a multiple-treatment design with two intervention phases, an ABACAA design. The study include a baseline assessment phase (A1), a three-month intervention phase with motion controlled video game training (B), post-intervention assessment (A2), a second three-month intervention phase with Motion Controlled Video Game (MCVG) treatment and BoNT-A treatment (C) including an assessment in the middle when BoNT-A usually have its peak (6 weeks after application) (A3), post-intervention assessment three months after application of BoNT-A (A4) and a follow-up assessment 9 months after beginning of first intervention (A5). All participants will be medically examined and assessed with functional measures in all assessment phases. The timeframe from baseline to follow-up is approximately 9 months.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04290169
- Collaborators
- Rigshospitalet, Denmark
- Göteborg University
- CP-foreningen
- Investigators
- Study Director: Per Ola Rike, Phd Sunnaas Rehabilitation Hospital
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