Robotic Rehabilitation and Brain Stimulation for Children With Hemiparetic Cerebral Palsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-25

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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The defining feature of hemiparetic cerebral palsy is motor impairments primarily on one side of the body. Robotic rehabilitation and non-invasive brain stimulation are both emerging technologies that may be beneficial in improving motor performance in individuals with hemiparetic cerebral palsy. Robotic rehabilitation can allow for hundreds of arm movements in the span of an hour, a level of concentrated repetitions that is not possible in traditional rehabilitation. Additionally, robotics can target specific deficits, such as coordinating both arms together, improving accuracy of reaching movements, or improving proprioception, while simultaneously giving the therapist and patient quantitative feedback on performance. Non-invasive brain stimulation using transcranial direct current stimulation (tDCS) can safely modulate activity in regions of the brain and has emerged as a tool to enhance motor learning in typically developing children and augment therapy in children with hemiparetic cerebral palsy.

Children with hemiparetic cerebral palsy will be randomized to receive robotic rehabilitation with tDCS or robotic rehabilitation with sham-tDCS. Participants and the assessors will be blinded to the treatment. All children will complete 10 sessions within 3 weeks of 1.5 hours of robotic rehabilitation. The Kinarm Exoskeleton Robot will be used and children will play games with their affected arm or both arms to target different aspects of sensorimotor control. Children will simultaneously receive real or sham tDCS for the first 20 minutes of the session. tDCS will consist of 1 mA current with the cathode applied over the contralesional M1 area. All children will be assessed before and after the 10 session intervention period using robotic and clinical measures of motor and sensory performance, and at a 3 month follow up.

Conditions

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Hemiplegic Cerebral Palsy Perinatal Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Robot Rehabilitation + tDCS

Intervention Type COMBINATION_PRODUCT

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

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.

Group Type SHAM_COMPARATOR

Robotic Rehabilitation + sham tDCS

Intervention Type BEHAVIORAL

Robotic therapy with Kinarm Exoskeleton Robot and sham tDCS.

Interventions

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Robot Rehabilitation + tDCS

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

Intervention Type COMBINATION_PRODUCT

Robotic Rehabilitation + sham tDCS

Robotic therapy with Kinarm Exoskeleton Robot and sham tDCS.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No