Parent Therapist Partnership to Provide Early, Intensive Exercise in Perinatal Stroke

NCT03672864 | Active Not Recruiting

• 1 other identifier: Pro00078553
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief Summary

A prospective, single blind, parallel group, randomized control trial to determine if early, intensive lower extremity activity delivered by a physical therapist and a parent in partnership improves gross motor function more than usual care.

Conditions

Perinatal Stroke

Keywords

Walking; Intensive exercise; Rehabilitation; Cerebral Palsy; Early intervention

Outcome Measures

Primary Outcomes (1)

• Gross Motor Function Measure (GMFM-66) - change from baseline

  A 66 item criterion referenced observational measure of gross motor skills designed for children with cerebral palsy.

  3 months, 6 months, 9 months, 12 months

Secondary Outcomes (7)

• The Pediatric Quality of Life Measure module for cerebral palsy (PedsQL CP) - change from baseline

  3 months, 6 months, 9 months, 12 months

• Ankle joint angle at onset of stretch reflex - change from baseline

  3 months, 6 months, 9 months, 12 months

• Ankle joint angle at full dorsiflexion - change from baseline

  3 months, 6 months, 9 months, 12 months

• Resource use questionnaire

  Baseline

• Resource use questionnaire

  6 months

Other Outcomes (1)

• Qualitative study using Interpretative Description methodology

  Immediately before and after the intervention

Study Arms (2)

Immediate Group

EXPERIMENTAL

The intervention is intensive exercise, delivered over 12 weeks beginning on admission to the study. The group will then be followed for 9 months post intervention.

Behavioral: Intensive exercise

Delay Group

NO INTERVENTION

The group will be followed for 6 months with no intervention. After 6 months the group will be given the opportunity to receive the same intensive exercise intervention as the Immediate group. The group will be followed for 3 months following the intervention.

Interventions

Intensive exercise BEHAVIORAL

Intensive, child-initiated movement of the lower extremity: 1 hour/day, 4 days/week, 2 sessions delivered by a physical therapist, 2 delivered by a parent. All activities are play based, and exercise intensity is enhanced by small weights placed on the dorsum of the foot and the ankle of the affected limb. Intervention is delivered over 12 weeks for a target of 48 hours of training.

Immediate Group

Eligibility Criteria

• Age: 8 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children ages 8 months to 3 years
• medical history and physical exam consistent with perinatal stroke
• hemiparesis in the upper and/or lower extremity
• parental agreement to adhere to the training and testing schedule

You may not qualify if:

• bilateral motor impairment
• epileptic seizures that could interfere with training
• cognitive, behavioural or developmental impairments that preclude participation in the protocol
• botulinum toxin A injections or surgery in the lower extremities within the previous six months
• concurrent casting during the intervention phase (including constraint-induced movement therapy with casting)
• diagnosis associated with neurological/developmental regression
• parent unable to communicate (verbal and written) in English or French

Sponsors & Collaborators

• University of Alberta: lead
• Brain Canada: collaborator

Study Sites (3)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

University of Alberta

Edmonton, Alberta, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Location

Related Publications (1)

• Hurd CL, Barnes M, Diot CM, Condliffe EG, Alazem H, Pritchard L, Zwicker JD, McCormick A, Watt MJ, Andersen J, Kirton A, Yang JF. Parent-therapist partnership to ELEVATE gross motor function in children with perinatal stroke: protocol for a mixed methods randomized controlled trial. BMC Pediatr. 2022 Aug 10;22(1):480. doi: 10.1186/s12887-022-03525-6.

  PMID: 35948896 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Jaynie Yang

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessing therapists are masked to the child's group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled trial

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 17, 2018
• Study Start: February 15, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)