Efficacy of Massage in Stroke Spasticity

NCT ID: NCT01448980

Last Updated: 2014-06-06

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Stroke; Sequelae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Physical therapy

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

Group Type ACTIVE_COMPARATOR

Physical therapy program

Intervention Type PROCEDURE

Physical therapy program 2 times per week for 6 weeks.

Thai Traditional Massage

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

Group Type EXPERIMENTAL

Thai Traditional Massage (TTM)

Intervention Type PROCEDURE

Thai Traditional Massage will receive massage 2 time per week for 6 weeks

Interventions

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Thai Traditional Massage (TTM)

Thai Traditional Massage will receive massage 2 time per week for 6 weeks

Intervention Type PROCEDURE

Physical therapy program

Physical therapy program 2 times per week for 6 weeks.

Intervention Type PROCEDURE

Other Intervention Names

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Thai Traditional Massage Physical therapy

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Vilai Kuptniratsaikul

Rehabilitation Medicine Department, Siriraj Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vilai Kuptniratsaikul, MD

Role: PRINCIPAL_INVESTIGATOR

Rehabilitation Medicine Department, Siriraj Hospital, Mahidol University

Locations

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Faculty of Medicine Siriraj Hospital

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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Thanakiatpinyo T, Suwannatrai S, Suwannatrai U, Khumkaew P, Wiwattamongkol D, Vannabhum M, Pianmanakit S, Kuptniratsaikul V. The efficacy of traditional Thai massage in decreasing spasticity in elderly stroke patients. Clin Interv Aging. 2014 Aug 11;9:1311-9. doi: 10.2147/CIA.S66416. eCollection 2014.

Reference Type DERIVED
PMID: 25143717 (View on PubMed)

Other Identifiers

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Si205/2011

Identifier Type: -

Identifier Source: org_study_id

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