Back to resultsEfficacy of Massage in Stroke Spasticity
Primary Purpose
Stroke; Sequelae
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Thai Traditional Massage (TTM)
Physical therapy program
Sponsored by
About this trial
This is an interventional treatment trial for Stroke; Sequelae focused on measuring massage, stroke spasticity
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine Siriraj Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Physical therapy
Thai Traditional Massage
Arm Description
The control group will receive physical therapy 2 time per week for 6 weeks
The experimental group will receive Thai traditional massage program 2 times per week for 6 weeks.
Outcomes
Primary Outcome Measures
Modified Ashworth scale (MAS)
The massage will be considered success if MAS decreased at least 1 level after treatment.
Secondary Outcome Measures
Modified Barthel index (BI)
Massage will be considered success if BI score increases after treatment.
Hospital anxiety depression score (HADS)
Massage will be considered success if HADS decreases after treatment.
Thai Pictorial Quality of Life questionnaire
Massage will be considered if Thai pictorial QoL score increases after treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01448980
Brief Title
Efficacy of Massage in Stroke Spasticity
Official Title
The Efficacy of Thai Traditional Massage in Decreasing Spasticity for Elderly With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke; Sequelae
Keywords
massage, stroke spasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
396 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical therapy
Arm Type
Active Comparator
Arm Description
The control group will receive physical therapy 2 time per week for 6 weeks
Arm Title
Thai Traditional Massage
Arm Type
Experimental
Arm Description
The experimental group will receive Thai traditional massage program 2 times per week for 6 weeks.
Intervention Type
Procedure
Intervention Name(s)
Thai Traditional Massage (TTM)
Other Intervention Name(s)
Thai Traditional Massage
Intervention Description
Thai Traditional Massage will receive massage 2 time per week for 6 weeks
Intervention Type
Procedure
Intervention Name(s)
Physical therapy program
Other Intervention Name(s)
Physical therapy
Intervention Description
Physical therapy program 2 times per week for 6 weeks.
Primary Outcome Measure Information:
Title
Modified Ashworth scale (MAS)
Description
The massage will be considered success if MAS decreased at least 1 level after treatment.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Modified Barthel index (BI)
Description
Massage will be considered success if BI score increases after treatment.
Time Frame
6 weeks
Title
Hospital anxiety depression score (HADS)
Description
Massage will be considered success if HADS decreases after treatment.
Time Frame
6 weeks
Title
Thai Pictorial Quality of Life questionnaire
Description
Massage will be considered if Thai pictorial QoL score increases after treatment.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vilai Kuptniratsaikul, MD
Organizational Affiliation
Rehabilitation Medicine Department, Siriraj Hospital, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
25143717
Citation
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.
Results Reference
derived
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Efficacy of Massage in Stroke Spasticity
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