Hemiplegic Cerebral PalsyPhase 2RoboCPNCT04233710
Robotic Rehabilitation and Brain Stimulation for Children With Hemiparetic Cerebral Palsy
A Phase 2 study testing Robot Rehabilitation + tDCS in people with Hemiplegic Cerebral Palsy and Perinatal Stroke, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy, Perinatal Stroke
- What is being tested?
- Robot Rehabilitation + tDCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 25 Mar 2019to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Rachel L Hawe, DPT, PhD, 403-944-1094, rachel.hawe@ucalgary.ca
About this study
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.
Read the detailed description
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
- Hemiplegic Cerebral Palsy, Perinatal Stroke
- Being tested
- Robot Rehabilitation + tDCS, Robotic Rehabilitation + sham tDCS
- Keywords
- robotic rehabilitation, tDCS, non-invasive brain stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot Rehabilitation + tDCSCombination product
Robotic therapy with Kinarm Exoskeleton Robot and 1 mA cathodal tDCS applied to contralesional M1 for 20 minutes.
Robotic Rehabilitation + sham tDCSBehavioural
Robotic therapy with Kinarm Exoskeleton Robot and sham tDCS.
| Study group | Role | What they receive |
|---|---|---|
| Robot + tDCS | Experimental | 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. Receives: Combination Product: Robot Rehabilitation + tDCS |
| Robot + sham tDCS | Sham comparator | 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. Receives: Behavioral: Robotic Rehabilitation + sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaching Accuracy
Change in reaching accuracy as measured by initial direction error on robotic visually guided reaching task.
Measured: change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
Secondary outcomes (4)
Standardized robotic measures of motor and sensory performance
Robotic measures of spatiotemporal reaching (path length ratio, reaction time, movement speed, number of speed maximums), proprioception (variability in position matching) and bilateral object hitting task (number of balls hit with each hand). Each measure will be assessed as change from pre-assessment to immediate post-assessment
Measured: change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
Assisting Hand Assessment
Performance on clinical assessment that determines how effectively the affected limb is used on tasks typically requiring both arms.
Measured: change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
Box and Block Assessment
Measure of ability to reach, grasp and release that measures how many 1" cubes a child can move from one side of a box to another in 1 minute.
Measured: change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
Purdue Pegboard
Measure of manual dexterity measured by how many small pegs a child can place in a pegboard in 30 seconds.
Measured: change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start25 Mar 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sean Dukelow, University of Calgary
- Investigators
- Sean P Dukelow, MD, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233710
- Sponsor's protocol ID
- REB17-1008
- Acronym
- RoboCP
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Raess L, Hawe RL, Metzler M, Zewdie E, Condliffe E, Dukelow SP, Kirton A. Robotic Rehabilitation and Transcranial Direct Current Stimulation in Children With Bilateral Cerebral Palsy. Front Rehabil Sci. 2022 Feb 25;3:843767. doi: 10.3389/fresc.2022.843767. eCollection 2022.
PubMed 36188922
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Rehabilitation and Brain Stimulation for Children With Hemiparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04233710
- Acronym / sponsor ID
- RoboCP / REB17-1008
- Conditions
- Hemiplegic Cerebral Palsy, Perinatal Stroke
- Keywords
- robotic rehabilitation, tDCS, non-invasive brain stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot + tDCS | Experimental | Combination Product: Robot Rehabilitation + tDCS10 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. |
| Robot + sham tDCS | Sham comparator | Behavioral: Robotic Rehabilitation + sham tDCS10 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot Rehabilitation + tDCSRobotic therapy with Kinarm Exoskeleton Robot and 1 mA cathodal tDCS applied to contralesional M1 for 20 minutes. | Combination product | Robot + tDCS |
| Robotic Rehabilitation + sham tDCSRobotic therapy with Kinarm Exoskeleton Robot and sham tDCS. | Behavioural | Robot + sham tDCS |
Primary outcome
Reaching Accuracy
Time frame: change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
Change in reaching accuracy as measured by initial direction error on robotic visually guided reaching task.
4 secondary outcomes
Standardized robotic measures of motor and sensory performance
Time frame: change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
Assisting Hand Assessment
Time frame: change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
Box and Block Assessment
Time frame: change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
Purdue Pegboard
Time frame: change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 36188922Raess L, Hawe RL, Metzler M, Zewdie E, Condliffe E, Dukelow SP, Kirton A. Robotic Rehabilitation and Transcranial Direct Current Stimulation in Children With Bilateral Cerebral Palsy. Front Rehabil Sci. 2022 Feb 25;3:843767. doi: 10.3389/fresc.2022.843767. eCollection 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean P Dukelow, MD, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Robot Rehabilitation + tDCS in people with Hemiplegic Cerebral Palsy and Perinatal Stroke, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel L Hawe, DPT, PhD (403-944-1094, rachel.hawe@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04233710, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.