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

NCT ID: NCT03094377

Last Updated: 2017-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-01

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This was a quasi-randomized-controlled pilot. Participants were randomly allocated by admission sequence to a multisensory therapy group or a conventional training group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Multisensory therapy

Intervention Type OTHER

Sensory stimulation, motor training and ADL training

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).

Group Type ACTIVE_COMPARATOR

Conventional training

Intervention Type OTHER

Motor training and ADL training

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Multisensory therapy

Sensory stimulation, motor training and ADL training

Intervention Type OTHER

Conventional training

Motor training and ADL training

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tung Wah College

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ray KF Li

Principal Investigator, Adjunct Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ray Li, Master

Role: PRINCIPAL_INVESTIGATOR

Occupational Therapist

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wong Tai Sin Hospital

Wong Tai Sin, , Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1193-6547

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.