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Efficacy of Massage in Stroke Spasticity

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT01448980
Collaborator
(none)
396
Enrollment
1
Location
2
Arms
25
Duration (Months)
15.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Stroke is one of the common diseases in the elderly. It is the third ranking cause of death and affects health care system in our country. One of the most important consequences of stroke is spasticity. Some stroke patients suffered from severe spasticity or hypersensitive reflex to stimuli. It can cause contracture, limit self care function, transfer or ambulation. Most of stroke patients have to depend on their relatives or families.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Thai Traditional Massage (TTM)
  • Procedure: Physical therapy program
 Phase 3

Detailed Description

Thai traditional massage is one of the popular alternative medicine in Thailand. Lots of stroke patients who suffered from spasticity sought treatment. To the investigators knowledge, there is no study concerning efficacy of massage in decreasing spasticity for stroke patients.

Study Design

Study Type:
Interventional
Actual Enrollment :
396 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Efficacy of Thai Traditional Massage in Decreasing Spasticity for Elderly With Stroke
Study Start Date :
May 1, 2012
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Physical therapy

The control group will receive physical therapy 2 time per week for 6 weeks

Procedure: Physical therapy program
Physical therapy program 2 times per week for 6 weeks.
Other Names:
  • Physical therapy

    		•
    Experimental: Thai Traditional Massage

    The experimental group will receive Thai traditional massage program 2 times per week for 6 weeks.

    Procedure: Thai Traditional Massage (TTM)
    Thai Traditional Massage will receive massage 2 time per week for 6 weeks
    Other Names:
  • Thai Traditional Massage

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Modified Ashworth scale (MAS) [6 weeks]

      The massage will be considered success if MAS decreased at least 1 level after treatment.

    Secondary Outcome Measures

    1. Modified Barthel index (BI) [6 weeks]

      Massage will be considered success if BI score increases after treatment.

    2. Hospital anxiety depression score (HADS) [6 weeks]

      Massage will be considered success if HADS decreases after treatment.

    3. Thai Pictorial Quality of Life questionnaire [6 weeks]

      Massage will be considered if Thai pictorial QoL score increases after treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Stroke with onset of >=6 months

    • Age >=50 years

    • Spasticity grade of knee flexor or elbow flexor was 2-3 classified by Modified Ashworth scale (MAS)

    • Ability to follow command and communicable

    Exclusion Criteria:

    • Having contraindications for massage including fever > 38 degree, uncontrolled blood pressure, bleeding tendency, on anticoagulant drug, having ulcer or healing fracture of limbs, contamination skin disease, severe osteoporosis

    • Serious contact diseases, for example AIDS, TB

    • History of malignancy

    • Fixed joint contracture at elbow or knee of paralyzed limb

    • History of botulinum toxin injection or Phenol/Alcohol nerve block within 3 months

    • Previous history of TTM

    • Severe dementia or uncontrolled psychiatric problems

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Siriraj Hospital Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Vilai Kuptniratsaikul, MD, Rehabilitation Medicine Department, Siriraj Hospital, Mahidol University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vilai Kuptniratsaikul, Rehabilitation Medicine Department, Siriraj Hospital, Mahidol University
    ClinicalTrials.gov Identifier:
    NCT01448980
    Other Study ID Numbers:
    • Si205/2011
    First Posted:
    Oct 7, 2011
    Last Update Posted:
    Jun 6, 2014
    Last Verified:
    Jun 1, 2014
    Keywords provided by Vilai Kuptniratsaikul, Rehabilitation Medicine Department, Siriraj Hospital, Mahidol University
    massage
    stroke spasticity
    Additional relevant MeSH terms:
    Muscle Spasticity
    Stroke

    Study Results

    No Results Posted as of Jun 6, 2014