Concomitant Sensory Stimulation During Therapy to Enhance Hand Functional Recovery Post Stroke
Primary Purpose
Stroke, Physical Disability
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
real stimulation
No stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring physical stimulation, subliminal stimulation, stroke rehabilitation, physical therapy, occupational therapy, upper extremity, paresis, hand function
Eligibility Criteria
Inclusion Criteria:
- 18 years old or older
- At least 6 months since stroke
- Wolf Motor Function Test (WMFT) total average time >10 seconds
- WFMT hand task average time <120 s
Exclusion Criteria:
- Currently undergoing other upper limb therapy
- Change in spasticity medication or upper limb botulinum toxin injection within 3 months prior to or during enrollment
- Severe spasticity that limits participation in task practice therapy (e.g., Modified Ashworth Scale=4-5)
- Comorbidity affecting the upper limb function such as complete upper extremity deafferentation, orthopaedic conditions limiting motion, premorbid neurologic conditions, premorbid peripheral neuropathy, compromised skin integrity of the wrist due to burn or long-term use of blood thinners, or significant new neurological symptoms
- Language barrier or cognitive impairment that precludes following instructions and/or providing consent
Sites / Locations
- Medical University of South CarolinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Vibration
No Vibration
Arm Description
The device will deliver imperceptible vibration for the treatment group.
The device will deliver no vibration for the control group.
Outcomes
Primary Outcome Measures
Change in Score of Wolf Motor Function Test (WMFT)
Timed test of upper extremity function with a variety of tasks.
Secondary Outcome Measures
Change in Score of Box and Blocks Test
Timed test of upper extremity function by moving blocks.
Change in Score of Action Research Arm Test
Timed test of upper extremity function through a variety of tasks.
Full Information
NCT ID
NCT04569123
First Posted
September 23, 2020
Last Updated
November 15, 2022
Sponsor
Medical University of South Carolina
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT04569123
Brief Title
Concomitant Sensory Stimulation During Therapy to Enhance Hand Functional Recovery Post Stroke
Official Title
Concomitant Sensory Stimulation During Therapy to Enhance Hand Functional Recovery Post Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to determine if combining vibration with hand task practice is superior to hand task practice alone.
Detailed Description
Stroke is a leading cause of disability in the U.S., with more than 4 million stroke survivors in the U.S. who suffer from post-stroke hand disability. Post-stroke hand disability impairs stroke survivors' abilities and independence with self-care, hygiene, employment, and leisure, frequently resulting in diminished quality of life. Rehabilitation can often be limited, but research suggests that the effects of therapy is improved by the addition of sensory stimulation.
To fully leverage the potential therapeutic benefits of sensory stimulation, we have developed a new stimulation that is imperceptible random-frequency vibration applied to wrist skin. The objective of this study is to determine if this treatment is superior to task-practice alone in improving hand functional recovery, sensorimotor grip control, and neural communication.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Physical Disability
Keywords
physical stimulation, subliminal stimulation, stroke rehabilitation, physical therapy, occupational therapy, upper extremity, paresis, hand function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vibration
Arm Type
Active Comparator
Arm Description
The device will deliver imperceptible vibration for the treatment group.
Arm Title
No Vibration
Arm Type
Sham Comparator
Arm Description
The device will deliver no vibration for the control group.
Intervention Type
Device
Intervention Name(s)
real stimulation
Intervention Description
Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver vibration for the treatment group.
Intervention Type
Device
Intervention Name(s)
No stimulation
Intervention Description
Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver no vibration for the control group during therapy.
Primary Outcome Measure Information:
Title
Change in Score of Wolf Motor Function Test (WMFT)
Description
Timed test of upper extremity function with a variety of tasks.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change in Score of Box and Blocks Test
Description
Timed test of upper extremity function by moving blocks.
Time Frame
Baseline and 6 weeks
Title
Change in Score of Action Research Arm Test
Description
Timed test of upper extremity function through a variety of tasks.
Time Frame
Baseline and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years old or older
At least 6 months since stroke
Wolf Motor Function Test (WMFT) total average time >10 seconds
WFMT hand task average time <120 s
Exclusion Criteria:
Currently undergoing other upper limb therapy
Change in spasticity medication or upper limb botulinum toxin injection within 3 months prior to or during enrollment
Severe spasticity that limits participation in task practice therapy (e.g., Modified Ashworth Scale=4-5)
Comorbidity affecting the upper limb function such as complete upper extremity deafferentation, orthopaedic conditions limiting motion, premorbid neurologic conditions, premorbid peripheral neuropathy, compromised skin integrity of the wrist due to burn or long-term use of blood thinners, or significant new neurological symptoms
Language barrier or cognitive impairment that precludes following instructions and/or providing consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Na Jin Seo, PhD
Phone
8437920084
Email
seon@musc.edu
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Na Jin Seo, PhD
Phone
843-792-0084
Email
seon@musc.edu
First Name & Middle Initial & Last Name & Degree
Na Jin Seo, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35382902
Citation
Seo NJ, Ramakrishnan V, Woodbury ML, Bonilha L, Finetto C, Schranz C, Scronce G, Coupland K, Blaschke J, Baker A, Howard K, Meinzer C, Velozo CA, Adams RJ. Concomitant sensory stimulation during therapy to enhance hand functional recovery post stroke. Trials. 2022 Apr 5;23(1):262. doi: 10.1186/s13063-022-06241-9.
Results Reference
derived
Learn more about this trial
Concomitant Sensory Stimulation During Therapy to Enhance Hand Functional Recovery Post Stroke
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