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Effect of Multisensory Stimulation on Upper Extremity Motor Recovery in Stroke Patient: a Preliminary Testing

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Multisensory therapy
Conventional training
Sponsored by
Tung Wah College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Multisensory stimulation; motor recovery

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • First-time ischemic or hemorrhagic stroke;
  • Stroke onset > 4 weeks and < 6 months
  • Single lesion
  • Upper extremity motor deficit
  • No severe cognitive impairment and able to follow verbal instructions.

Exclusion Criteria:

  • Skin conditions/ injuries over the stimulation application areas
  • Contraindication for cold or vibration application
  • Speech disorder or global aphasia
  • Musculoskeletal or cardiac disorders
  • Other neurological conditions
  • History of diabetes or sensory impairment attributable to peripheral vascular disease or neuropathy

Sites / Locations

  • Wong Tai Sin Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multisensory therapy group

Conventional training group

Arm Description

The Multisensory therapy (MT) group received a 12-weeks (two sessions/ week; 90 minutes/session) training conducted by an occupational therapist. Each session began with 15 minutes of sensory stimulation (cold and vibration), 45 minutes of motor training and 30 minutes of self-care training.

The conventional training (CT) group included 12 weeks (two sessions/ week; 90 minutes/session) training conducted by an occupational therapist. Each session included 60 minutes of upper extremity motor practice (same as in MT group) and 30 minutes of self-care training (same as in MT group).

Outcomes

Primary Outcome Measures

Change from baseline Fugl-Meyer Assessment of Motor Recovery at 3 months
The Fugl-Meyer Assessment was used to assess the progress in synergistic and voluntary movement at baseline and post intervention.
Change from baseline Functional Test for the Hemiplegic Upper Extremity at 3 months
The Functional Test for the Hemiplegic Upper Extremity was used to evaluate the recovery of the hemiplegic upper extremity functions at baseline and post intervention.

Secondary Outcome Measures

Change from baseline Modified Barthel Index at 3 months
The Modified Barthel Index was used to measure functional performance in basic activities of daily living at baseline and post intervention.
Change from baseline Manual Muscle testing at 3 months
Manual muscle testing (MMT) was used for the evaluation of the motor recovery and strength of upper extremity muscle groups at baseline and post intervention.

Full Information

First Posted
March 13, 2017
Last Updated
March 23, 2017
Sponsor
Tung Wah College
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1. Study Identification

Unique Protocol Identification Number
NCT03094377
Brief Title
Effect of Multisensory Stimulation on Upper Extremity Motor Recovery in Stroke Patient: a Preliminary Testing
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
December 31, 2015 (Actual)
Study Completion Date
December 31, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tung Wah College

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
Despite the advances in stroke rehabilitation, post-stroke upper extremity impairment is still a major challenge. Increasing evidence can be found supporting stimulation of the afferent receptor enhances neuroplasticity in the brain. Studies have suggested multisensory stimulation could promote motor learning by re-establishing the disrupted sensorimotor loop due to stroke and enhance neuroplasticity. The objective of the study was to examine the effect of multisensory stimulation on upper-extremity motor recovery and self-care function in stroke patients.
Detailed Description
Stroke patients referred to occupational therapy division of geriatric day hospital will be recruited and randomly assigned to a multisensory therapy group or a conventional training group. The Multisensory therapy group received 12 weeks (two sessions/ week; 90 minutes/session) training. Each session began with 15 minutes of sensory stimulation (cold and vibration), 45 minutes of motor training and 30 minutes of self-care training. The conventional training group included 12 weeks (two sessions/ week; 90 minutes/session) training. Each session included 60 minutes of upper extremity motor practice and 30 minutes of self-care training. Outcome measures included: Brunnstrom's stage, Fugl-Meyer Assessment Scale and Functional Test for the Hemiplegic Upper Extremity were used for upper limb motor control and function; and Manual muscle testing was used for muscle strength. The modified Barthel Index was used for self-care performance

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Multisensory stimulation; motor recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This was a quasi-randomized-controlled pilot. Participants were randomly allocated by admission sequence to a multisensory therapy group or a conventional training group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multisensory therapy group
Arm Type
Experimental
Arm Description
The Multisensory therapy (MT) group received a 12-weeks (two sessions/ week; 90 minutes/session) training conducted by an occupational therapist. Each session began with 15 minutes of sensory stimulation (cold and vibration), 45 minutes of motor training and 30 minutes of self-care training.
Arm Title
Conventional training group
Arm Type
Active Comparator
Arm Description
The conventional training (CT) group included 12 weeks (two sessions/ week; 90 minutes/session) training conducted by an occupational therapist. Each session included 60 minutes of upper extremity motor practice (same as in MT group) and 30 minutes of self-care training (same as in MT group).
Intervention Type
Other
Intervention Name(s)
Multisensory therapy
Intervention Description
Sensory stimulation, motor training and ADL training
Intervention Type
Other
Intervention Name(s)
Conventional training
Intervention Description
Motor training and ADL training
Primary Outcome Measure Information:
Title
Change from baseline Fugl-Meyer Assessment of Motor Recovery at 3 months
Description
The Fugl-Meyer Assessment was used to assess the progress in synergistic and voluntary movement at baseline and post intervention.
Time Frame
Baseline and post intervention at week 12
Title
Change from baseline Functional Test for the Hemiplegic Upper Extremity at 3 months
Description
The Functional Test for the Hemiplegic Upper Extremity was used to evaluate the recovery of the hemiplegic upper extremity functions at baseline and post intervention.
Time Frame
Baseline and post intervention at week 12
Secondary Outcome Measure Information:
Title
Change from baseline Modified Barthel Index at 3 months
Description
The Modified Barthel Index was used to measure functional performance in basic activities of daily living at baseline and post intervention.
Time Frame
Baseline and post intervention at week 12
Title
Change from baseline Manual Muscle testing at 3 months
Description
Manual muscle testing (MMT) was used for the evaluation of the motor recovery and strength of upper extremity muscle groups at baseline and post intervention.
Time Frame
Baseline and post intervention at week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: First-time ischemic or hemorrhagic stroke; Stroke onset > 4 weeks and < 6 months Single lesion Upper extremity motor deficit No severe cognitive impairment and able to follow verbal instructions. Exclusion Criteria: Skin conditions/ injuries over the stimulation application areas Contraindication for cold or vibration application Speech disorder or global aphasia Musculoskeletal or cardiac disorders Other neurological conditions History of diabetes or sensory impairment attributable to peripheral vascular disease or neuropathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ray Li, Master
Organizational Affiliation
Occupational Therapist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wong Tai Sin Hospital
City
Wong Tai Sin
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Share all the available data as requested

Learn more about this trial

Effect of Multisensory Stimulation on Upper Extremity Motor Recovery in Stroke Patient: a Preliminary Testing

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