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

NCT03094377 | Completed DMC

• 1 other identifier: U1111-1193-6547
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Multisensory stimulation; motor recovery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change from baseline Modified Barthel Index at 3 months

  Baseline and post intervention at week 12

• Change from baseline Manual Muscle testing at 3 months

  Baseline and post intervention at week 12

Study Arms (2)

Multisensory therapy group

EXPERIMENTAL

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

Conventional training group

ACTIVE COMPARATOR

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

Interventions

Multisensory therapy OTHER

Sensory stimulation, motor training and ADL training

Multisensory therapy group

Conventional training OTHER

Motor training and ADL training

Conventional training group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tung Wah College: lead

Study Sites (1)

Wong Tai Sin Hospital

Wong Tai Sin, Hong Kong

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Ray Li, Master

  Occupational Therapist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Adjunct Lecturer

Model Details: This was a quasi-randomized-controlled pilot. Participants were randomly allocated by admission sequence to a multisensory therapy group or a conventional training group

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 29, 2017
• Study Start: March 1, 2015
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: March 29, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

HK (1)