Efficacy of Massage in Stroke Spasticity

Phase 3

Completed

• Conditions: Stroke; Sequelae
• Interventions: Procedure: Physical therapy program; Procedure: Thai Traditional Massage (TTM)

• Registration Number: NCT01448980
• Lead Sponsor: Mahidol University

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 Timeline

• Study First Submitted: 2011-10-05
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Study Start: 2012-05
• Status Verified: 2014-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-05
• Last Update Posted: 2014-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 396

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical therapy	Physical therapy program	The control group will receive physical therapy 2 time per week for 6 weeks
Thai Traditional Massage	Thai Traditional Massage (TTM)	The experimental group will receive Thai traditional massage program 2 times per week for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Modified Ashworth scale (MAS)	6 weeks	The massage will be considered success if MAS decreased at least 1 level after treatment.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand