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

June 14, 2019 updated by: Kristina Lämås, Umeå University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Umea, Sweden, 90187
        • Norrlands University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Touch massage
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
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
Sham Comparator: non-TENS
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Investigators

  • Principal Investigator: Kristina Lämås, PhD, Umeå University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

May 27, 2013

First Submitted That Met QC Criteria

June 19, 2013

First Posted (Estimate)

June 21, 2013

Study Record Updates

Last Update Posted (Actual)

June 18, 2019

Last Update Submitted That Met QC Criteria

June 14, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-494-32M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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