Sensory Stimulation to Enhance Hand Function Post Stroke

NCT02675764 | Completed Results

• 2 other identifiers: PRO42759P20GM109040
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this pilot project is to assess the impact of the novel sensory stimulation technique the investigators have developed in enhancing outcomes of hand therapy as well as the central nervous system responsiveness in chronic stroke survivors.

Conditions

Stroke

Keywords

hand function

Outcome Measures

Primary Outcomes (4)

• Box and Block Test (BBT) About a Week After the 2-week Intervention

  Change in hand motor function as measured by the Box and Block Test. This test measures the number of blocks that a participant moved in a minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.

  post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy)

• Box and Block Test (BBT) at Least 2 Weeks After the 2-week Intervention

  Change in hand motor function as measured by the Box and Block Test. This test measures the number of blocks that a participant moved in a minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.

  follow up (at least 2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)

• WMFT About a Week After the 2-week Intervention

  change in hand motor function as measured by the Wolf Motor Function Test hand items time. This test measures time to complete movements in seconds. More negative values represent greater reduction in time and thus better outcomes.

  post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy)

• WMFT at Least 2 Weeks After the 2-week Intervention

  change in hand motor function as measured by the Wolf Motor Function Test hand items time. This test measures time to complete movements in seconds. More negative values represent greater reduction in time and thus better outcomes.

  follow up (2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)

Study Arms (2)

Experimental

EXPERIMENTAL

The experimental group receives the wrist subthreshold vibrotactile stimulation during therapy.

Other: Vibration; Behavioral: therapy

Placebo

ACTIVE COMPARATOR

The control group will wear the vibration device with no vibration. * Both groups cannot feel the vibration since the vibration intensity is set below the perceptible level. * The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.

Other: Placebo (for vibration); Behavioral: therapy

Interventions

Vibration OTHER

peripheral vibration at the wrist skin at an imperceptible level

Experimental

Placebo (for vibration) OTHER

No peripheral vibration at the wrist skin

Placebo

therapy BEHAVIORAL

standardized hand therapy program

Experimental; Placebo

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mild to moderate impairment in upper extremity function

You may not qualify if:

• cognitive dysfunction
• stroke\<3 months
• treatment with botulinum toxin in the affected arm within 3 months of start of study

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• Seo NJ, Woodbury ML, Bonilha L, Ramakrishnan V, Kautz SA, Downey RJ, Dellenbach BHS, Lauer AW, Roark CM, Landers LE, Phillips SK, Vatinno AA. TheraBracelet Stimulation During Task-Practice Therapy to Improve Upper Extremity Function After Stroke: A Pilot Randomized Controlled Study. Phys Ther. 2019 Mar 1;99(3):319-328. doi: 10.1093/ptj/pzy143.

  PMID: 30690609 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Vibration; Therapeutics

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Results Point of Contact

• Title: Dr. Na Jin Seo
• Organization: Medical University of South Carolina

seon@musc.edu

8437920084

Study Officials

• Steven Kautz, PhD

  Medical University of South Carolina

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: February 5, 2016
• Study Start: January 1, 2016
• Primary Completion: March 30, 2017
• Study Completion: March 30, 2017
• Last Updated: March 27, 2024
• Results First Posted: August 8, 2018

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)