Does Physiotherapy Plus Non-invasive Brain Stimulation Improve Motor Recovery in Children With Acquired Brain Injury?

NCT04422886 | Terminated DMC

• 1 other identifier: 19-857
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The current study will evaluate the feasibility of transcranial direct current stimulation (tDCS) combined with an existing intensive physiotherapy program for children with ABI within the in/day-patient brain injury program at Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada. This feasibility randomized control trial will allocate 30 participants with ABI (age 5 to 18 years) to one of two treatment groups. One group will receive active tDCS prior to four of their existing physiotherapy sessions each week for a total of 16 sessions while the other group will receive sham/placebo tDCS prior to their physiotherapy sessions. Recovery of gross motor function will be compared between groups after the four weeks of tDCS treatment and again after three months to evaluate the short and longer-term impact of tDCS on an existing intensive physiotherapy program. Feasibility will be evaluated by tracking process, resource, and treatment indicators such as eligibility, enrollment, adherence, and tolerance rates.

Conditions

Acquired Brain Injury; Recovery of Function; Transcranial Electrical Stimulation

Keywords

physical therapy; pediatric; motor recovery; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (7)

• Gross Motor Function Measure

  A standardized physiotherapy assessment (validated for children with ABI) that assesses gross motor function in five dimensions (A- lying \& rolling, B- sitting, C- crawling \& kneeling, D- standing, walking, E-running \& jumping). Each of the 88 items is scored from 0-3.

  Change from baseline to 1st reassessment (4 weeks) to 2nd reassessment (3 months)

• Canadian Occupational Performance Measure

  The Canadian Occupational Performance Measure is a standardized outcome measure that allows children and families to set goals and evaluate their performance and satisfaction with each goal on a scale of 1 to 10, where higher ratings mean increased performance and satisfaction. In this study, the goals will be participation-based goals related to gross motor activities.

  Change from baseline to 1st reassessment (4 weeks) to 2nd reassessment (3 months)

• Eligibility Rate

  The proportion of eligible participants compared to the number of children admitted for inpatient brain injury rehabilitation. Reported as a percentage.

  Through study completion, an average of two years

• Enrollment Rate

  The proportion of eligible participants who enrollment in the study. Reported as a percentage

  Through study completion, an average of two years

• Adherence Rate

  The proportion of enrolled participants who complete at least 12 of the 16 transcranial direct current stimulation (followed by physiotherapy) sessions.

  Through study completion, an average of two years

• Transcranial Direct Current Stimulation Tolerance

  The mean dose (measured in milliamperes) of transcranial direct current stimulation each participant receives.

  Through study completion, an average of two years

• Transcranial Direct Current Stimulation Tolerability Questionnaire

  At baseline the participant indicate the most enjoyable and least enjoyable activity they have experienced in the last month. They order these two activities in relation to 7 familiar childhood experiences (e.g., watching TV, going to the dentist, going for a long car ride). At followup, the child is presented with the baseline ordering of these 9 activities and asked to indicate where transcranial direct current stimulation fits in the order (e.g. more enjoyable than going to the dentist but less enjoyable than watching TV).

  1st reassessment (after 4-week treatment protocol)

Secondary Outcomes (4)

• Acquired Brain Injury Challenge Assessment

  Change from baseline to 1st reassessment (4 weeks) to 2nd reassessment (3 months)

• 10 metre fastest walk test

  Change from baseline to 1st reassessment (4 weeks) to 2nd reassessment (3 months)

• Goal Attainment Scaling

  Change from baseline to 1st reassessment (4 weeks) to 2nd reassessment (3 months)

• Pediatric Evaluation of Disability Inventory (Mobility and Self-Care domains)

  Change from baseline to 1st reassessment (4 weeks) to 2nd reassessment (3 months)

Study Arms (2)

Physio+tDCS

EXPERIMENTAL

Receives 20 minutes of active tDCS immediately prior to physiotherapy session, 4 days per week for a total of 16 sessions.

Device: active transcranial direct current stimulation (tDCS); Behavioral: Physiotherapy

Physio+sham

SHAM COMPARATOR

Receives 20 minutes of sham tDCS immediately prior to physiotherapy session, 4 days per week for a total of 16 sessions.

Behavioral: Physiotherapy; Device: sham transcranial direct current stimulation (sham)

Interventions

active transcranial direct current stimulation (tDCS) DEVICE

20 minutes at 2.0 mA with electrodes positioned at Cz and Fpz (as per 10-20 electrode placement guidelines)

Physio+tDCS

Physiotherapy BEHAVIORAL

motor skills based physiotherapy intervention (representative of typical goal-focused intervention in the clinical ABI program at Holland Bloorview), 45 minutes in duration

Physio+sham; Physio+tDCS

sham transcranial direct current stimulation (sham) DEVICE

1 minutes at 1.0 mA with electrodes positioned at Cz and Fpz (as per 10-20 electrode placement guidelines) and 19 minutes with unit shut off and electrodes remaining on the scalp

Physio+sham

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• sustained a cerebral stroke (ischaemic or haemorrhage) or TBI within the last three months;
• admitted to Holland Bloorview for intensive brain injury rehabilitation in the in/day patient programs;
• medically stable, as determined by their primary physician at Holland Bloorview;
• receiving active motor learning-based physiotherapy intervention four to five times per week, as prescribed by their treating PT;
• tolerate approximately 45 minutes of physiotherapy intervention;
• able to sit at the edge of the bed independently for 5s
• capable of participating in standardized physiotherapy assessment, from a cognitive and behavioural perspective, and;
• able to communicate discomfort (verbally or non-verbally).

You may not qualify if:

• primary injury of the cerebellum
• pre-existing seizure disorder (i.e., prior to ABI);
• anti-seizure medication not optimized at the time of study enrollment (i.e., physician is actively adjusting type or dose of anti-seizure medication)
• brain tumour;
• metal implants in the head;
• cranial bone flap removed;
• stitches/staples or open wound on the head;
• experience with tDCS in the last two years (as knowledge of the sensation of active tDCS will affect blinding of treatment groups);
• diagnosed with another neurological disorder(s) affecting gross motor function (e.g., cerebral palsy, spinal cord injury, guillain-barre syndrome, etc…);
• requires more than 15 minutes per physiotherapy treatment session of non-motor learning content (e.g., behavioural redirection, craniosacral therapy, vestibular therapy, passive range of motion)
• lower extremity weight bearing activity restrictions secondary to injuries (e.g., fracture, ligamentous injury)(at the time of study enrollment)
• non-orthopaedic physical activity restrictions secondary to other injuries (e.g., splenic laceration)
• balances on most affected leg for greater than 5s
• enrolment in another treatment-based research study

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G 1R8, Canada

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Deryk S Beal, PhD

  Clinician Scientist

  PRINCIPAL INVESTIGATOR

• Virginia Wright, PhD

  Clinican Scientist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Physiotherapists providing treatment, physiotherapists conducting assessment, research coordinator, principal investigators, participants are all blinded to treatment allocation. Research assistants administered the transcranial direct current stimulation are not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2-arm parallel group feasibility randomized control trial

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: June 9, 2020
• Study Start: January 15, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)