Effects of Touch Massage in the Sub-acute Phase After Stroke (MEST)
Primary Purpose
Stroke
Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Touch massage
non-TENS
Sponsored by

About this trial
This is an interventional supportive care trial for Stroke focused on measuring Stroke, Massage, General Health, Independence
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:individuals with
- cancerous tumors,
- infections with fever,
- neurologic or psychiatric disease,
- alcohol or drug addiction,
- conditions that impede communication.
Sites / Locations
- Norrlands university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Touch massage
non-TENS
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
VAS
To assess self-rated pain
Nottingham Health Profile
This is a self-rating scale which assess Health related quality of life
ECG
evaluate heart rate variability which reflects activity in the autonomic nervous system
Salivary cortisol
To assess effects on stress responses
Blood pressure
to assess effects on stress responses
Shape Texture Identification Test
will be used to assess touch discrimination
Box and Blocks
will be used to test gross dexterity
Nine Hole Peg
will be used to test fine motor dexterity,
Jamar® Hydraulic Hand Dynamometer
will be used to assess grip strength
movement laboratory with high-speed cameras
Temporal and spatial kinematic variables will be evaluated
Functional magnetic resonance imaging
Evaluation of brain activity while patient perform finger-tapping/movement with the paretic hand
Barthel index and Modified Ranking scale
will be used to assess disability after stroke
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01883947
Brief Title
Effects of Touch Massage in the Sub-acute Phase After Stroke
Acronym
MEST
Official Title
Touch Massage in the Sub-acute Phase After Stroke - Does it Have Impact on General Health and Independence?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
too long inclusion phase due to difficulties to find eligible participants.
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Massage, General Health, Independence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Touch massage
Arm Type
Experimental
Arm Description
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
Arm Title
non-TENS
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Touch massage
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
non-TENS
Intervention Description
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.
Primary Outcome Measure Information:
Title
State-Trait Anxiety Scale
Description
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
Time Frame
2 month
Secondary Outcome Measure Information:
Title
VAS
Description
To assess self-rated pain
Time Frame
2 weeks
Title
Nottingham Health Profile
Description
This is a self-rating scale which assess Health related quality of life
Time Frame
2 weeks
Title
ECG
Description
evaluate heart rate variability which reflects activity in the autonomic nervous system
Time Frame
2 weeks
Title
Salivary cortisol
Description
To assess effects on stress responses
Time Frame
2 weeks
Title
Blood pressure
Description
to assess effects on stress responses
Time Frame
2 weeks
Title
Shape Texture Identification Test
Description
will be used to assess touch discrimination
Time Frame
2 month
Title
Box and Blocks
Description
will be used to test gross dexterity
Time Frame
2 month
Title
Nine Hole Peg
Description
will be used to test fine motor dexterity,
Time Frame
2 month
Title
Jamar® Hydraulic Hand Dynamometer
Description
will be used to assess grip strength
Time Frame
2 month
Title
movement laboratory with high-speed cameras
Description
Temporal and spatial kinematic variables will be evaluated
Time Frame
2 month
Title
Functional magnetic resonance imaging
Description
Evaluation of brain activity while patient perform finger-tapping/movement with the paretic hand
Time Frame
2 weeks
Title
Barthel index and Modified Ranking scale
Description
will be used to assess disability after stroke
Time Frame
2 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:individuals with
cancerous tumors,
infections with fever,
neurologic or psychiatric disease,
alcohol or drug addiction,
conditions that impede communication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina Lämås, PhD
Organizational Affiliation
Umea University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norrlands university hospital
City
Umea
ZIP/Postal Code
90187
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26846253
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Touch Massage in the Sub-acute Phase After Stroke
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