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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03094377
Other study ID # U1111-1193-6547
Secondary ID
Status Completed
Phase N/A
First received March 13, 2017
Last updated March 23, 2017
Start date March 1, 2015
Est. completion date December 31, 2015

Study information

Verified date March 2017
Source Tung Wah College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 31, 2015
Est. primary completion date December 31, 2015
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Multisensory therapy
Sensory stimulation, motor training and ADL training
Conventional training
Motor training and ADL training

Locations

Country Name City State
Hong Kong Wong Tai Sin Hospital Wong Tai Sin

Sponsors (1)

Lead Sponsor Collaborator
Tung Wah College

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
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