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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Multisensory therapy; Other: Conventional training

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Wong Tai Sin, Hong Kong
    • Wong Tai Sin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multisensory therapy group; 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.	Other: Multisensory therapy; Sensory stimulation, motor training and ADL training
Active Comparator: Conventional training group; 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).	Other: Conventional training; Motor training and ADL training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and post intervention at week 12
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.	Baseline and post intervention at week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and post intervention at week 12
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.	Baseline and post intervention at week 12

Collaborators and Investigators

• Sponsor: Tung Wah College
• Investigators: Principal Investigator: Ray Li, Master, Occupational Therapist

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: March 13, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Multisensory stimulation; motor recovery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: U1111-1193-6547

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Share all the available data as requested

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No