Comparing CIMT With Virtual Reality to CIMT

NCT06506682 | Completed DMC

• 1 other identifier: STU 2021-0271
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to compare constraint induced movement therapy (CIMT) to CIMT combined with virtual reality technology (CIMT+VR) and its impact on how the children with unilateral cerebral palsy use their arm. CIMT is an intensive upper limb therapy for children with one sided (unilateral) cerebral palsy where the child wears a constraint (splint or mit) on their dominant hand so that they use the involved (weaker) side to do activities. Both groups will work on using both arms together to complete activities (bimanual training) as a way to transfer newly learned skills with one hand into two handed tasks. Assessments before and after the intervention will include clinical assessments (where a research team member observes the child doing tasks and ask questions), motion capture (where the child's movement is recorded using multiple cameras), and wearable sensors on the wrists (like a watch).

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Assisting Hand Assessment (AHA)

  assessment of bimanual hand skills in children with cerebral palsy well the involved hand performs during two handed activities,

  Baseline, pre-intervention and immediate post-intervention

Secondary Outcomes (7)

• Melbourne Unilateral Upper Limb Assessment (MUUL)

  Baseline, pre-intervention and immediate post-intervention

• ICF Brief Core Set for Cerebral Palsy

  Baseline, pre-intervention

• Hypertonia Assessment Tool Assessment Tool (HAT)

  Baseline, pre-intervention and immediate post-intervention

• Canadian Occupational Performance Measure Occupational Performance Measure (COPM)

  Baseline, pre-intervention and immediate post-intervention

• sensory assessment

  Baseline, pre-intervention and immediate post-intervention

Study Arms (2)

CIMT

ACTIVE COMPARATOR

Both groups will participate in 60 hours of intensive therapy over 10 days at SRC (6 hours per day Monday-Friday) following the established 'Pirate Camp' CIMT protocol. The full protocol can be found at: https://twu.edu/occupational-therapy/Camp-Based-Augmented-CIMT-Guide/. Both groups will participate in child friendly outdoor and indoor activities that promote the use of the involved side for example; parachute games, sock toss, penny pick up.

Behavioral: Constraint Induced Movement Therapy

CIMT+VR

EXPERIMENTAL

The CIMT+VR group will use the VR technology to work on upper limb motor skills for approximately two hours per day (4 of the activities described under Key Information at the beginning of this form) while the CIMT-only group will participate in traditional motor-based task-specific activities. Both the VR games and traditional intervention will target the improvement of the same upper limb domains.

Behavioral: CIMT + VR

Interventions

Constraint Induced Movement Therapy BEHAVIORAL

CIMT is an intensive upper limb therapy for children with unilateral (one sided) cerebral palsy where the child wears a constraint (splint or mit) on their dominant hand so that they use the involved (weaker) side to do activities

Also known as: CIMT

CIMT

CIMT + VR BEHAVIORAL

Participants in the CIMT+VR group of this study protocol will do everything the CIMT group does PLUS will utilize at least 4 of the following VR technologies each day of intervention: FitMi, Tyromotion Pablo® UpperExtremity, Hocoma Armeo® Spring Pediatric, Nintendo Wii, and Parrot Drone.

CIMT+VR

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• have cerebral palsy (a brain injury that causes muscle movement problems) or are a non-progressive brain injury to the developing brain and have difficulty using one of your arms

You may not qualify if:

• unable to complete assessment protocol

Sponsors & Collaborators

• Texas Scottish Rite Hospital for Children: lead
• Texas Woman's University: collaborator

Study Sites (1)

Scottish Rite for Children

Dallas, Texas, 75219, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: July 17, 2024
• Study Start: May 17, 2021
• Primary Completion: July 22, 2022
• Study Completion: May 1, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)