Stroke; SequelaePhase 3NCT01448980
Efficacy of Massage in Stroke Spasticity
A Phase 3 study testing Thai Traditional Massage (TTM) and Physical therapy program in people with Stroke; Sequelae, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke; Sequelae
- What is being tested?
- Thai Traditional Massage (TTM) and Physical therapy program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 1 siteThailand
- Study dates
- May 2012to Jun 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke; Sequelae
- Being tested
- Thai Traditional Massage (TTM), Physical therapy program
- Keywords
- massage, stroke spasticity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thai Traditional Massage (TTM)Procedure or surgery
Also called Thai Traditional Massage
Thai Traditional Massage will receive massage 2 time per week for 6 weeks
Physical therapy programProcedure or surgery
Also called Physical therapy
Physical therapy program 2 times per week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Physical therapy | Active comparator | The control group will receive physical therapy 2 time per week for 6 weeks Receives: Procedure: Physical therapy program |
| Thai Traditional Massage | Experimental | The experimental group will receive Thai traditional massage program 2 times per week for 6 weeks. Receives: Procedure: Thai Traditional Massage (TTM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth scale (MAS)
The massage will be considered success if MAS decreased at least 1 level after treatment.
Measured: 6 weeks
Secondary outcomes (3)
Modified Barthel index (BI)
Massage will be considered success if BI score increases after treatment.
Measured: 6 weeks
Hospital anxiety depression score (HADS)
Massage will be considered success if HADS decreases after treatment.
Measured: 6 weeks
Thai Pictorial Quality of Life questionnaire
Massage will be considered if Thai pictorial QoL score increases after treatment.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startMay 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke; SequelaeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vilai Kuptniratsaikul, Mahidol University
- Investigators
- Vilai Kuptniratsaikul, MD, Principal investigator, Rehabilitation Medicine Department, Siriraj Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448980
- Sponsor's protocol ID
- Si205/2011
- Status last verified
- Jun 2014
- First submitted
- 5 Oct 2011
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25143717
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Thai Traditional Massage in Decreasing Spasticity for Elderly With Stroke
- ClinicalTrials.gov ID
- NCT01448980
- Acronym / sponsor ID
- Si205/2011
- Conditions
- Stroke; Sequelae
- Keywords
- massage, stroke spasticity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical therapy | Active comparator | Procedure: Physical therapy programThe control group will receive physical therapy 2 time per week for 6 weeks |
| Thai Traditional Massage | Experimental | Procedure: Thai Traditional Massage (TTM)The experimental group will receive Thai traditional massage program 2 times per week for 6 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thai Traditional Massage (TTM)Also: Thai Traditional MassageThai Traditional Massage will receive massage 2 time per week for 6 weeks | Procedure or surgery | Thai Traditional Massage |
| Physical therapy programAlso: Physical therapyPhysical therapy program 2 times per week for 6 weeks. | Procedure or surgery | Physical therapy |
Primary outcome
Modified Ashworth scale (MAS)
Time frame: 6 weeks
The massage will be considered success if MAS decreased at least 1 level after treatment.
3 secondary outcomes
Modified Barthel index (BI)
Time frame: 6 weeks
Hospital anxiety depression score (HADS)
Time frame: 6 weeks
Thai Pictorial Quality of Life questionnaire
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
- Derived from this study: PubMed 25143717Thanakiatpinyo 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.
Related trials for Stroke; Sequelae
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Ischemic Stroke in the Sequelae Stage
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Effects of Different-Frequency Electroacupuncture on Suprahyoid Muscles in Post-Stroke Dysphagia: Efficacy and Neural Networks
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Active, not recruitingObservational study
A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development
Spasticity as Sequela of Stroke
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TDCS to Improve Post-Stroke Cognitive Impairment
Stroke, Stroke Sequelae
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vilai Kuptniratsaikul, MD principal investigator
Rehabilitation Medicine Department, Siriraj Hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thai Traditional Massage (TTM) and Physical therapy program in people with Stroke; Sequelae, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth scale (MAS) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01448980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2014.