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Clinical Trials/NCT01448980
NCT01448980CompletedPhase 3

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

Mahidol University1 site in 1 country396 target enrollmentStarted: May 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
396
Locations
1
Primary Endpoint
Modified Ashworth scale (MAS)

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

Physical therapy

Active Comparator

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

Intervention: Physical therapy program (Procedure)

Thai Traditional Massage

Experimental

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

Intervention: Thai Traditional Massage (TTM) (Procedure)

Outcomes

Primary Outcomes

Modified Ashworth scale (MAS)

Time Frame: 6 weeks

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

Secondary Outcomes

  • Modified Barthel index (BI)(6 weeks)
  • Hospital anxiety depression score (HADS)(6 weeks)
  • Thai Pictorial Quality of Life questionnaire(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Vilai Kuptniratsaikul

Rehabilitation Medicine Department, Siriraj Hospital

Mahidol University

Study Sites (1)

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