StrokeMESTNCT01883947
Effects of Touch Massage in the Sub-acute Phase After Stroke
A study testing Touch massage and non-TENS in people with Stroke, run by Umeå University at 1 site in Sweden.
Trial summary
The aim is to study effects of touch massage in the sub-acute phase after stroke in two main areas; general health and independence.The hypothesis are that; touch massage in the sub-acute phase after stroke decreases anxiety and pain, increases health related-quality of life, decrease physiological stress responses… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Touch massage and non-TENS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2013to Jun 2018
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- stroke defined according to Trial of ORG 10172 in Acute Stroke Treatment (TOAST) and The Oxford Community Stroke Project Classification (OSPC),
- impaired finger tapping on the affected side of the body,
- the ability to flex the wrist 20° from substrate on affected side of the body
Who cannot join
- cancerous tumors,
- infections with fever,
- neurologic or psychiatric disease,
- alcohol or drug addiction,
- conditions that impede communication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Touch Massage in the Sub-acute Phase After Stroke - Does it Have Impact on General Health and Independence?
The aim is to study effects of touch massage in the sub-acute phase after stroke in two main areas; general health and independence.The hypothesis are that; touch massage in the sub-acute phase after stroke decreases anxiety and pain, increases health related-quality of life, decrease physiological stress responses, increase sensorimotor function, decrease disability, and increase activity in sensorimotor areas and decrease redundant brain activity in motor-related areas.
Read the detailed description
Despite high quality stroke care in Sweden, decreased sensorimotor function, anxiety and pain remains one year after stroke and lead to impaired health and dependence as well as high health care costs. It is therefore urgent to find new rehabilitation strategies. There is some knowledge about effects of touch massage among healthy and patients with ill-health conditions but no study have evaluated touch massage in the sub-acute phase of stroke. Therefore the aim in this project is to study effects of t touch massage in the sub-acute phase after stroke in two main areas; general health and independence.
- Conditions
- Stroke
- Being tested
- Touch massage, non-TENS
- Keywords
- Stroke, Massage, General Health, Independence
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Touch massageProcedure or surgery
Touch massage is a gentle massage with strokes on hands, arms, feet and legs with at pressure of 2.5 N which is more gentle than Swedish massage but harder than strokes performed with a brush. The speed of the strokes is about 1-5 cm/sec. During the massage, the subjects will lie on a bed. Intervention group will receive touch massage on hands and feet and the intervention will start one week after the onset of stroke and last for 30 minutes each time, five days a week for two weeks
non-TENSOther
Subjects in the control group will have sham treatment which is a non-active transcutaneous electrical nerve stimulation (non-TENS), while they lie in bed with electrodes attached to the skin of the affected arm. The device will be manipulated in a way so that no electrical impulses will reach the electrodes. During treatment, the masseur will remain in the room without initiating any conversation.
| Study group | Role | What they receive |
|---|---|---|
| Touch massage | Experimental | Intervention group will receive touch massage on hands and feet and the intervention will start one week after the onset of stroke and last for 30 minutes each time, five days a week for two weeks Receives: Procedure: Touch massage |
| non-TENS | Sham comparator | The sham treatment will start one week after the onset of stroke and last for 30 minutes each time, five days a week for two weeks Receives: Other: non-TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Scale
Assessment of self-rated anxiety on two subscales. Traits are stable over time and not sensitive to occasional stressors. States are sensitive for occasional stressors assessing current emotional state
Measured: 2 month
Secondary outcomes (12)
VAS
To assess self-rated pain
Measured: 2 weeks
Nottingham Health Profile
This is a self-rating scale which assess Health related quality of life
Measured: 2 weeks
ECG
evaluate heart rate variability which reflects activity in the autonomic nervous system
Measured: 2 weeks
Salivary cortisol
To assess effects on stress responses
Measured: 2 weeks
Blood pressure
to assess effects on stress responses
Measured: 2 weeks
Shape Texture Identification Test
will be used to assess touch discrimination
Measured: 2 month
Box and Blocks
will be used to test gross dexterity
Measured: 2 month
Nine Hole Peg
will be used to test fine motor dexterity,
Measured: 2 month
Jamar® Hydraulic Hand Dynamometer
will be used to assess grip strength
Measured: 2 month
movement laboratory with high-speed cameras
Temporal and spatial kinematic variables will be evaluated
Measured: 2 month
Functional magnetic resonance imaging
Evaluation of brain activity while patient perform finger-tapping/movement with the paretic hand
Measured: 2 weeks
Barthel index and Modified Ranking scale
will be used to assess disability after stroke
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2017
- Study completionJun 2018
Why it stopped: too long inclusion phase due to difficulties to find eligible participants.
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 StrokeStudies of the same condition, open and under way.
- More trials run by Umeå 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Lämås, Umeå University
- Investigators
- Kristina Lämås, PhD, Principal investigator, Umea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883947
- Sponsor's protocol ID
- 2012-494-32M
- Acronym
- MEST
- Status last verified
- Jun 2019
- First submitted
- 27 May 2013
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lamas K, Hager C, Lindgren L, Wester P, Brulin C. Does touch massage facilitate recovery after stroke? A study protocol of a randomized controlled trial. BMC Complement Altern Med. 2016 Feb 4;16:50. doi: 10.1186/s12906-016-1029-9.
PubMed 26846253
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Touch Massage in the Sub-acute Phase After Stroke - Does it Have Impact on General Health and Independence?
- ClinicalTrials.gov ID
- NCT01883947
- Acronym / sponsor ID
- MEST / 2012-494-32M
- Conditions
- Stroke
- Keywords
- Stroke, Massage, General Health, Independence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: too long inclusion phase due to difficulties to find eligible participants.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 21 Jun 2013 (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.
The aim is to study effects of touch massage in the sub-acute phase after stroke in two main areas; general health and independence.The hypothesis are that; touch massage in the sub-acute phase after stroke decreases anxiety and pain, increases health related-quality of life, decrease physiological stress responses, increase sensorimotor function, decrease disability, and increase activity in sensorimotor areas and decrease redundant brain activity in motor-related areas.
Detailed description
Despite high quality stroke care in Sweden, decreased sensorimotor function, anxiety and pain remains one year after stroke and lead to impaired health and dependence as well as high health care costs. It is therefore urgent to find new rehabilitation strategies. There is some knowledge about effects of touch massage among healthy and patients with ill-health conditions but no study have evaluated touch massage in the sub-acute phase of stroke. Therefore the aim in this project is to study effects of t touch massage in the sub-acute phase after stroke in two main areas; general health and independence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Touch massage | Experimental | Procedure: Touch massageIntervention group will receive touch massage on hands and feet and the intervention will start one week after the onset of stroke and last for 30 minutes each time, five days a week for two weeks |
| non-TENS | Sham comparator | Other: non-TENSThe sham treatment will start one week after the onset of stroke and last for 30 minutes each time, five days a week for two weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- stroke defined according to Trial of ORG 10172 in Acute Stroke Treatment (TOAST) and The Oxford Community Stroke Project Classification (OSPC),
- impaired finger tapping on the affected side of the body,
- the ability to flex the wrist 20° from substrate on affected side of the body
Key exclusion criteria (5 listed)
- cancerous tumors,
- infections with fever,
- neurologic or psychiatric disease,
- alcohol or drug addiction,
- conditions that impede communication.
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 |
|---|---|---|
| Touch massageTouch massage is a gentle massage with strokes on hands, arms, feet and legs with at pressure of 2.5 N which is more gentle than Swedish massage but harder than strokes performed with a brush. The speed of the strokes is about 1-5 cm/sec. During the massage, the subjects will lie on a bed. Intervention group will receive touch massage on hands and feet and the intervention will start one week after the onset of stroke and last for 30 minutes each time, five days a week for two weeks | Procedure or surgery | Touch massage |
| non-TENSSubjects in the control group will have sham treatment which is a non-active transcutaneous electrical nerve stimulation (non-TENS), while they lie in bed with electrodes attached to the skin of the affected arm. The device will be manipulated in a way so that no electrical impulses will reach the electrodes. During treatment, the masseur will remain in the room without initiating any conversation. | Other | non-TENS |
Primary outcome
State-Trait Anxiety Scale
Time frame: 2 month
Assessment of self-rated anxiety on two subscales. Traits are stable over time and not sensitive to occasional stressors. States are sensitive for occasional stressors assessing current emotional state
12 secondary outcomes
VAS
Time frame: 2 weeks
Nottingham Health Profile
Time frame: 2 weeks
ECG
Time frame: 2 weeks
Salivary cortisol
Time frame: 2 weeks
Blood pressure
Time frame: 2 weeks
Shape Texture Identification Test
Time frame: 2 month
Box and Blocks
Time frame: 2 month
Nine Hole Peg
Time frame: 2 month
Jamar® Hydraulic Hand Dynamometer
Time frame: 2 month
movement laboratory with high-speed cameras
Time frame: 2 month
Functional magnetic resonance imaging
Time frame: 2 weeks
Barthel index and Modified Ranking scale
Time frame: 2 month
Results and safety
The study was stopped early (reason given: too long inclusion phase due to difficulties to find eligible participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Derived from this study: PubMed 26846253Lamas K, Hager C, Lindgren L, Wester P, Brulin C. Does touch massage facilitate recovery after stroke? A study protocol of a randomized controlled trial. BMC Complement Altern Med. 2016 Feb 4;16:50. doi: 10.1186/s12906-016-1029-9.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Kristina Lämås, PhD principal investigator
Umea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Touch massage and non-TENS in people with Stroke, run by Umeå University at 1 site in Sweden.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 18 Jun 2019. 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 Sweden. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: too long inclusion phase due to difficulties to find eligible participants.). Results are not available in the source record.
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?
State-Trait Anxiety Scale (time frame: 2 month). 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 NCT01883947, 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 18 Jun 2019.