Vibration + CIMT for Hemiparesis

(CPT Trial)

Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Medical University of South Carolina

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding gentle vibrations to constraint-induced movement therapy (CIMT) can improve hand function more than CIMT alone. CIMT involves restricting the unaffected hand to encourage use of the weakened hand. Participants will wear either a vibrating or non-vibrating watch during therapy sessions. The trial seeks individuals with one-sided arm weakness who can still use the affected arm for basic activities like play and self-care. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance therapeutic options for improving hand function.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe for improving hand function in hemiparesis?

Research has shown that using vibration therapy alongside other treatments is generally safe for people recovering from a stroke. One study found that using a vibrating device on the wrist daily for a month was safe for stroke survivors. Another study confirmed the safety of a similar type of vibration therapy over six weeks. These findings suggest that adding vibration to therapy does not cause harm.

Overall, vibration therapy has been tested in various ways and is well-tolerated by patients. Serious side effects have not been commonly reported, making it a promising addition to traditional rehabilitation methods.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores an innovative approach to enhancing Constraint-induced Movement Therapy (CIMT) for hemiparesis. Unlike traditional CIMT, which focuses solely on restricting the use of the unaffected limb to improve function in the affected one, this trial introduces a vibrating watch worn on the affected wrist during therapy. The vibration is thought to provide additional sensory feedback, potentially enhancing motor learning and recovery. This novel integration of sensory stimulation could offer a more effective rehabilitation strategy for individuals with hemiparesis, making it a promising development in the field.

What evidence suggests that vibration during CIMT could be effective for improving hand function in hemiparesis?

Research has shown that vibration therapy can improve movement and reduce muscle stiffness in individuals with nerve-related conditions. One study found that it helped stroke survivors move their arms more effectively. Another study demonstrated improved movement skills and reduced muscle stiffness. In this trial, participants will wear either a vibrating watch or a non-vibrating watch during constraint-induced movement therapy (CIMT). These findings suggest that adding vibration to treatments like CIMT might enhance hand use in individuals with one-sided weakness. While promising, results can vary for each person.678910

Who Is on the Research Team?

NJ

Na Jin Seo, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for individuals with unilateral upper limb motor weakness due to conditions like peripheral neuropathy or hemiparesis. Participants should be able to use their affected arm as an assist and walk appropriately for their age with good balance in the less affected arm.

Inclusion Criteria

I can walk and have good balance and control in my less affected arm.
I have weakness in one arm.
I can use my affected arm for basic tasks and play.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo constraint-induced movement therapy (CIMT) with or without vibration for up to 5 consecutive days

1 week
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Constraint-induced Movement Therapy
  • Vibration
Trial Overview The study aims to see if adding low-level vibration to constraint-induced movement therapy (CIMT) improves hand function better than just CIMT alone. It's a comparison between two different ways of doing therapy for people with arm weakness.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Wear vibrating watch during therapyExperimental Treatment2 Interventions
Group II: Wear non-vibrating watch during therapyPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

Published Research Related to This Trial

A preliminary phase II trial with 20 adults showed that Constraint-Induced Movement Therapy (CIMT) significantly improved real-world use of the affected arm in patients with multiple sclerosis (MS), with an average increase of 2.7 points on the Motor Activity Log compared to only 0.5 points in the complementary and alternative medicine (CAM) group.
The benefits of CIMT were not only significant but also long-lasting, as improvements were maintained at a 1-year follow-up, and the therapy was well tolerated with no reported adverse events.
Phase II Randomized Controlled Trial of Constraint-Induced Movement Therapy in Multiple Sclerosis. Part 1: Effects on Real-World Function.Mark, VW., Taub, E., Uswatte, G., et al.[2019]
Constraint-induced (CI) movement therapy significantly improves the use of the affected upper extremity in stroke patients by encouraging them to use their impaired arm for many hours each day over 10 to 14 days.
The therapy has shown lasting benefits, with increased arm use in daily activities persisting for up to 2 years, and patients who are likely to benefit can be identified prior to treatment.
Constraint Induced Movement Techniques To Facilitate Upper Extremity Use in Stroke Patients.Taub, E., Wolf, SL.[2016]

Citations

Efficacy and safety of whole-body vibration therapy for post ...The current study aims to assess the efficacy and safety of WBV for post-stroke spasticity and determine the appropriate application situation.
Upper extremity function and disability recovery with vibration ...This study aimed to investigate the therapeutic effects of vibration therapy for improving upper extremity motor impairment, function, and disability recovery ...
Exploring the Impact of Muscle Vibration Therapy in ...Vibration therapy has shown promising outcomes for alleviating pain, managing spasticity, and improving motor function in various neurologic conditions such as ...
Focal Vibration Therapy for Motor Deficits and Spasticity ...Results: The included studies demonstrated significant reductions in spasticity and improvements in motor function in most patients receiving ...
Effectiveness of a rehabilitation program involving functional ...Wang et al. reported that vibration therapy effectively improves upper limb motor function in patients with subacute stroke.
Using subthreshold vibratory stimulation during post-stroke ...The stimulation was feasible/safe for 6-week use. Preliminary efficacy encourages a larger trial to further evaluate the stimulation as a therapy adjunct.
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/31444692/
Extended Daily Peripheral Sensory Stimulation Using a Wrist ...Daily stimulation using the device for a month is safe for chronic stroke survivors. Future studies examining the efficacy of pairing ...
Efficacy and safety of whole-body vibration therapy for post ...Results: In this analysis, 11 RCTs with 475 patients that reported on the effectiveness of WBV therapy for post-stroke spasticity were taken ...
Impact of whole-body vibration training on ankle joint ...This study demonstrates that WBV therapy is equally effective as conventional methods in enhancing proprioception and balance in stroke patients ...
User Participatory Design of a Wearable Focal Vibration ...Thus, this study aimed to design and develop a novel wearable focal vibration device for upper limb rehabilitation in stroke survivors. A user ...
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