Recruiting
Phase 2

Robotic Rehabilitation

Sponsor:

University of Calgary

Code:

NCT04233710

Conditions

Hemiplegic Cerebral Palsy

Perinatal Stroke

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

Interventions

Robot Rehabilitation + tDCS

Robotic Rehabilitation + sham tDCS

Study Details

Brief summary:

This study evaluates the use of robotic rehabilitation with and without transcranial direct current stimulation (tDCS) to improve motor performance in children with hemiparetic cerebral palsy. Half of the participants will receive robotic rehabilitation and half will receive robotic rehabilitation with tDCS. We hypothesize that tDCS may augment the robotic therapy and show greater improvements than robotic therapy alone.

Conditions

Hemiplegic Cerebral Palsy

Perinatal Stroke

Study ID

NCT04233710

Start date

Mar 25, 2019

Status verified date

Jan, 2020

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • confirmed diagnosis of hemiparetic cerebral palsy due to unilateral perinatal stroke
  • age 6-18 years
  • Manual Ability Classification System (MACS) Level I-III
  • Modified Ashworth Score in shoulder and elbow <=3;
  • Visual acuity (corrected) better than 20/50 in both eyes
  • able to follow instructions and comply with protocol;
  • able to give consent/assent;
  • able to commit to all assessment and intervention sessions.

Exclusion Criteria:

  • significant contractures in the upper extremity;
  • other neurological conditions or active medical disease;
  • unstable epilepsy;
  • contraindications to tDCS;
  • botulinum toxin A injections in the upper extremity in the past 6 months;
  • upper extremity surgical intervention in past 6 months;
  • involvement in another interventional study.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Robot + tDCS

10 sessions of 1.5 hrs of robotic therapy within a 3 week period, with 20 minutes of 1mA cathodal tDCS applied to the contralesional M1 area during first 20 minutes of robotic therapy. Robotic therapy will be conducted using the Kinarm Exoskeleton robot and use games to target unilateral and bilateral motor and sensory impairments.

sham comparator: Robot + sham tDCS

10 sessions of 1.5 hrs of robotic therapy within a 3 week period with 20 minutes of SHAM tDCS applied during the first 20 minutes of the robotic therapy. As with experimental arm, electrode will be placed on contralesional M1. Current will ramp up and then immediately ramp down to simulate the cutaneous sensations felt with actual tDCS. Robotic therapy will be delivered with Kinarm Exoskeleton robot and use games to target unilateral and bilateral motor and sensory impairments.

Interventions

Robot Rehabilitation + tDCS

Robotic therapy with Kinarm Exoskeleton Robot and 1 mA cathodal tDCS applied to contralesional M1 for 20 minutes.

Robotic Rehabilitation + sham tDCS

Robotic therapy with Kinarm Exoskeleton Robot and sham tDCS.

Primary outcome measure

  • Reaching Accuracy [ Time Frame: change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention) ]

Central Contacts and Locations

Central contacts

Rachel L Hawe, DPT, PhD

403-944-1094rachel.hawe@ucalgary.ca

Sean P Dukelow, MD, PhD

403-944-5930spdukelo@ucalgary.ca

Locations

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Contacts

Rachel L Hawe, DPT, PhD

403-944-1094rachel.hawe@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

Jan 18, 2020

Last verified

Jan, 2020

Keywords

  • robotic rehabilitation
  • tDCS
  • non-invasive brain stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2020-01-18.