Cerebral Palsy, Perinatal Stroke
Conditions
Brief summary
The purpose of the study is to assess implementation and effectiveness of a caregiver-delivered rehabilitation intervention for infants and toddlers with cerebral palsy.
Interventions
BEHAVIORALHome-based Therapy
The 18-week caregiver-delivered intervention involves daily 30-minute home-practice and weekly sessions with a therapist over video call or in-person at a local rehabilitation centre. During weekly sessions, the therapist will coach the caregiver(s), problem-solving with them and supporting their autonomy as agents of change in their child's care. The first 13-weeks of the program will be exclusively constraint-induced movement therapy, with bimanual therapy introduced in the last five weeks depending on child age. Intervention content will be individualized based on child age, ability, and interests.
Sponsors
University of Calgary
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
* aged three to 24 months (corrected, if premature) * clinician-identified hand asymmetry * suspected/confirmed cerebral palsy (hemiplegia or triplegia) * willing to withhold other formal upper-limb focussed treatment during the study intervention - willing to commit to completing 18 weeks of daily home-practice and attending weekly therapy sessions.
Exclusion criteria
* participation in formal constraint induced movement therapy (CIMT) within last six months * upper limb botulinum toxin A injections within previous six months * brachial plexus injury * lower motor neuron dysfunction * upper limb congenital limb difference.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of therapists | <7 days after the 18-week intervention | Satisfaction with the intervention will be assessed using a study-built questionnaire with Likert-scale response options 0 to 4, with 4 being greater satisfaction. |
| Canadian Occupational Performance Measure (COPM) | <7 days after the 18-week intervention | Using the COPM, three to five individualized functional goals will be identified by caregivers and then scored on a scale of 1 to 10 for both Performance and Satisfaction. |
| Age-appropriate hand assessment (HAI/mini-AHA/AHA) | <7 days after the 18-week intervention | The HAI/mini-AHA/AHA employ a video-recorded play-based session of \<15 minutes to provide a logit-based measure of manual function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Canadian Occupational Performance Measure (COPM) | 8 weeks +/-3days after the the 18-week intervention. | Using the COPM, three to five individualized functional goals will be identified by caregivers and then scored on a scale of 1 to 10 for both Performance and Satisfaction. |
| Age-appropriate hand assessment (HAI/mini-AHA/AHA) | 8 weeks +/-3days after the the 18-week intervention. | The HAI/mini-AHA/AHA employ a video-recorded play-based session of \<15 minutes to provide a logit-based measure of manual function. |
Countries
Canada
Outcome results
None listed