Cerebral PalsyNCT03558230
Sensory Stimulation During CIMT
A study testing Standardized Constraint-Induced Movement Therapy and Vibration in people with Cerebral Palsy, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The long-term goal of this project is to assess the impact of the novel sensory stimulation technique in enhancing outcomes of constraint-induced movement therapy (CIMT) in children with cerebral palsy. This is a pilot project. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Standardized Constraint-Induced Movement Therapy and Vibration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2018to 28 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 9 years
- All sexes
- No healthy volunteers
- Child
- Between the ages of 3 and 9
- Have unilateral upper limb motor weakness.
- Use the affected extremity as a gross assist during play and self-care activities.
- No significant developmental delays that would limit spontaneous use of the more affected extremity.
- Be ambulatory for their age and demonstrate intact balance and protective reactions throughout the less involved upper extremity.
- No other health impairment other than hemiparesis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29403
About this study
Official title: Sensory Stimulation During Constraint-Induced Movement Therapy
The long-term goal of this project is to assess the impact of the novel sensory stimulation technique in enhancing outcomes of constraint-induced movement therapy (CIMT) in children with cerebral palsy. This is a pilot project.
Read the detailed description
The stimulation is peripheral sensory stimulation involving application of low-level, random-frequency vibration to the wrist skin. The hypothesis is that improvement in upper extremity function will be greater for the experimental group receiving the stimulation during CIMT compared with the control group who will wear the device with no vibration (placebo). This pilot study is to assess feasibility and safety.
- Conditions
- Cerebral Palsy
- Being tested
- Standardized Constraint-Induced Movement Therapy, Vibration, Placebo (for vibration)
- Keywords
- pediatric, hemiplegic, hand function
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Constraint-Induced Movement TherapyBehavioural
The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.
VibrationBehavioural
Vibration applied to the wrist.
Placebo (for vibration)Behavioural
No vibration applied to the wrist.
| Study group | Role | What they receive |
|---|---|---|
| Vibration | Experimental | The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy. Receives: Behavioral: Standardized Constraint-Induced Movement Therapy; Behavioral: Vibration |
| No Vibration | Placebo comparator | The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy.
* The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose. Receives: Behavioral: Standardized Constraint-Induced Movement Therapy; Behavioral: Placebo (for vibration) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (Total Number of Hours That Participants Wear the Device)
total number of hours that participants wear the device
Measured: through 5-day study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start16 Jul 2018
- Primary completion28 Oct 2018
- Study completion28 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Na Jin Seo, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558230
- Sponsor's protocol ID
- PRO74164
- Status last verified
- Nov 2018
- First submitted
- 7 May 2018
- Last updated
- 8 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Stimulation During Constraint-Induced Movement Therapy
- ClinicalTrials.gov ID
- NCT03558230
- Acronym / sponsor ID
- PRO74164
- Conditions
- Cerebral Palsy
- Keywords
- pediatric, hemiplegic, hand function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 28 Oct 2018 (actual)
- Study completion
- 28 Oct 2018 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Posted 8 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The long-term goal of this project is to assess the impact of the novel sensory stimulation technique in enhancing outcomes of constraint-induced movement therapy (CIMT) in children with cerebral palsy. This is a pilot project.
Detailed description
The stimulation is peripheral sensory stimulation involving application of low-level, random-frequency vibration to the wrist skin. The hypothesis is that improvement in upper extremity function will be greater for the experimental group receiving the stimulation during CIMT compared with the control group who will wear the device with no vibration (placebo). This pilot study is to assess feasibility and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibration | Experimental | Behavioral: Standardized Constraint-Induced Movement Therapy, Behavioral: VibrationThe experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy. |
| No Vibration | Placebo comparator | Behavioral: Standardized Constraint-Induced Movement Therapy, Behavioral: Placebo (for vibration)The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy. * The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Standardized Constraint-Induced Movement TherapyThe standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days. | Behavioural | No Vibration, Vibration |
| VibrationVibration applied to the wrist. | Behavioural | Vibration |
| Placebo (for vibration)No vibration applied to the wrist. | Behavioural | No Vibration |
Primary outcome
Feasibility (Total Number of Hours That Participants Wear the Device)
Time frame: through 5-day study completion.
total number of hours that participants wear the device
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Na Jin Seo, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Constraint-Induced Movement Therapy and Vibration in people with Cerebral Palsy, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 8 Mar 2019. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (Total Number of Hours That Participants Wear the Device) (time frame: through 5-day study completion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2019.