Effects of Touch Massage in the Sub-acute Phase After Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Touch Massage in the Sub-acute Phase After Stroke - Does it Have Impact on General Health and Independence?

Conditions
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Stroke

Intervention / Treatment
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* Procedure: Touch massage
* Other: non-TENS


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Touch massage<br>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: Touch massage<br>* 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<br>|
| Sham Comparator: non-TENS<br>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 | Other: non-TENS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS | To assess self-rated pain | 2 weeks | 
| Nottingham Health Profile | This is a self-rating scale which assess Health related quality of life | 2 weeks | 
| ECG | evaluate heart rate variability which reflects activity in the autonomic nervous system | 2 weeks | 
| Salivary cortisol | To assess effects on stress responses | 2 weeks | 
| Blood pressure | to assess effects on stress responses | 2 weeks | 
| Shape Texture Identification Test | will be used to assess touch discrimination | 2 month | 
| Box and Blocks | will be used to test gross dexterity | 2 month | 
| Nine Hole Peg | will be used to test fine motor dexterity, | 2 month | 
| Jamar® Hydraulic Hand Dynamometer | will be used to assess grip strength | 2 month | 
| movement laboratory with high-speed cameras | Temporal and spatial kinematic variables will be evaluated | 2 month | 
| Functional magnetic resonance imaging | Evaluation of brain activity while patient perform finger-tapping/movement with the paretic hand | 2 weeks | 
| Barthel index and Modified Ranking scale | will be used to assess disability after stroke | 2 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Massage, General Health, Independence