HemiparesisCPTNCT06452576
Use of Vibration During Constraint-induced Movement Therapy
A study testing Vibration and constraint-induced movement therapy in people with Hemiparesis, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the hand function will improve more by using low-level vibration during constraint-induced movement therapy (CIMT), compared to CIMT alone without vibration. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Hemiparesis
- What is being tested?
- Vibration and constraint-induced movement therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2024to 9 Sep 2024
- Phase
- Interventional
- 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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Unilateral upper limb motor weakness
- Can use the affected upper limb as a gross assist during play and self-care activities
- Ambulatory for their age with intact balance and protective reactions in the less involved upper limb.
Who cannot join
- Developmental delays limiting spontaneous use of the affected upper limb
- Other health impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
The purpose of this study is to determine whether the hand function will improve more by using low-level vibration during constraint-induced movement therapy (CIMT), compared to CIMT alone without vibration.
Read the detailed description
The low-level vibration has been shown to increase therapy outcome when used as an adjunct to therapy in adults with hemiparesis. Children who participates in the CIMT camp at MUSC will be recruited to take part in the study. Participating children will wear a watch device on their weaker arm during CIMT. The watch will vibrate only for the children who were assigned to the treatment group.
- Conditions
- Hemiparesis
- Being tested
- Vibration, constraint-induced movement therapy
- Keywords
- constraint-induced movement therapy
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibrationDevice
Watch vibrates.
constraint-induced movement therapyBehavioural
A splint or mitt is placed on the stronger, unaffected hand to encourage use of the affected upper limb in therapy.
| Study group | Role | What they receive |
|---|---|---|
| Wear vibrating watch during therapy | Experimental | The watch worn on the affected wrist vibrates during therapy. Receives: Device: Vibration; Behavioral: constraint-induced movement therapy |
| Wear non-vibrating watch during therapy | Placebo comparator | The watch worn on the affected wrist does not vibrate during therapy. Receives: Behavioral: constraint-induced movement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Block Test
number of blocks moved in a minute
Measured: pre-therapy and post-therapy, up to 5 consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start15 Jul 2024
- Primary completion9 Sep 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Na Jin Seo, Medical University of South Carolina
- Investigators
- Na Jin Seo, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452576
- Sponsor's protocol ID
- Pro00137672
- Acronym
- CPT
- Status last verified
- Jul 2025
- First submitted
- 4 Jun 2024
- Last updated
- 7 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Vibration During Constraint-induced Movement Therapy
- ClinicalTrials.gov ID
- NCT06452576
- Acronym / sponsor ID
- CPT / Pro00137672
- Conditions
- Hemiparesis
- Keywords
- constraint-induced movement therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 11 Jun 2024 (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.
The purpose of this study is to determine whether the hand function will improve more by using low-level vibration during constraint-induced movement therapy (CIMT), compared to CIMT alone without vibration.
Detailed description
The low-level vibration has been shown to increase therapy outcome when used as an adjunct to therapy in adults with hemiparesis. Children who participates in the CIMT camp at MUSC will be recruited to take part in the study. Participating children will wear a watch device on their weaker arm during CIMT. The watch will vibrate only for the children who were assigned to the treatment group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wear vibrating watch during therapy | Experimental | Device: Vibration, Behavioral: constraint-induced movement therapyThe watch worn on the affected wrist vibrates during therapy. |
| Wear non-vibrating watch during therapy | Placebo comparator | Behavioral: constraint-induced movement therapyThe watch worn on the affected wrist does not vibrate during therapy. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Unilateral upper limb motor weakness
- Can use the affected upper limb as a gross assist during play and self-care activities
- Ambulatory for their age with intact balance and protective reactions in the less involved upper limb.
Key exclusion criteria (2 listed)
- Developmental delays limiting spontaneous use of the affected upper limb
- Other health impairment
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 |
|---|---|---|
| VibrationWatch vibrates. | Device | Wear vibrating watch during therapy |
| constraint-induced movement therapyA splint or mitt is placed on the stronger, unaffected hand to encourage use of the affected upper limb in therapy. | Behavioural | Wear non-vibrating watch during therapy, Wear vibrating watch during therapy |
Primary outcome
Box and Block Test
Time frame: pre-therapy and post-therapy, up to 5 consecutive days
number of blocks moved in a minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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 Vibration and constraint-induced movement therapy in people with Hemiparesis, 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?
The sponsor lists 3 inclusion and 2 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: finished, as of the sponsor's last update on 7 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Box and Block Test (time frame: pre-therapy and post-therapy, up to 5 consecutive days). 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 7 Jul 2025.