Efficacy of Massage in Stroke Spasticity

June 5, 2014 updated by: Vilai Kuptniratsaikul, Mahidol University

The Efficacy of Thai Traditional Massage in Decreasing Spasticity for Elderly With Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

396

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth scale (MAS)
Time Frame: 6 weeks
The massage will be considered success if MAS decreased at least 1 level after treatment.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Barthel index (BI)
Time Frame: 6 weeks
Massage will be considered success if BI score increases after treatment.
6 weeks
Hospital anxiety depression score (HADS)
Time Frame: 6 weeks
Massage will be considered success if HADS decreases after treatment.
6 weeks
Thai Pictorial Quality of Life questionnaire
Time Frame: 6 weeks
Massage will be considered if Thai pictorial QoL score increases after treatment.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 5, 2011

First Submitted That Met QC Criteria

October 6, 2011

First Posted (Estimate)

October 7, 2011

Study Record Updates

Last Update Posted (Estimate)

June 6, 2014

Last Update Submitted That Met QC Criteria

June 5, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si205/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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