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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Umeå University
Sponsor:
Information provided by (Responsible Party):
Kristina Lämås, Umeå University
ClinicalTrials.gov Identifier:
NCT01883947
First received: May 27, 2013
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Stroke
Procedure: Touch massage
Other: non-TENS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Touch Massage in the Sub-acute Phase After Stroke - Does it Have Impact on General Health and Independence?

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • State-Trait Anxiety Scale [ Time Frame: 2 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    To assess self-rated pain

  • Nottingham Health Profile [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    This is a self-rating scale which assess Health related quality of life

  • ECG [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    evaluate heart rate variability which reflects activity in the autonomic nervous system

  • Salivary cortisol [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    To assess effects on stress responses

  • Blood pressure [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    to assess effects on stress responses

  • Shape Texture Identification Test [ Time Frame: 2 month ] [ Designated as safety issue: No ]
    will be used to assess touch discrimination

  • Box and Blocks [ Time Frame: 2 month ] [ Designated as safety issue: No ]
    will be used to test gross dexterity

  • Nine Hole Peg [ Time Frame: 2 month ] [ Designated as safety issue: No ]
    will be used to test fine motor dexterity,

  • Jamar® Hydraulic Hand Dynamometer [ Time Frame: 2 month ] [ Designated as safety issue: No ]
    will be used to assess grip strength

  • movement laboratory with high-speed cameras [ Time Frame: 2 month ] [ Designated as safety issue: No ]
    Temporal and spatial kinematic variables will be evaluated

  • Functional magnetic resonance imaging [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Evaluation of brain activity while patient perform finger-tapping/movement with the paretic hand

  • Barthel index and Modified Ranking scale [ Time Frame: 2 month ] [ Designated as safety issue: No ]
    will be used to assess disability after stroke


Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stroke defined according to TOAST and OCSP,
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01883947

Contacts
Contact: Kristina Lämås, PhD +46907869121 kristina.lamas@umu.se

Locations
Sweden
Department of Nursing, Umea University Recruiting
Umea, Sweden, 90187
Principal Investigator: Kristina Lämås, PhD         
Sponsors and Collaborators
Umeå University
  More Information

No publications provided

Responsible Party: Kristina Lämås, PhD, Umeå University
ClinicalTrials.gov Identifier: NCT01883947     History of Changes
Other Study ID Numbers: 2012-494-32M
Study First Received: May 27, 2013
Last Updated: August 30, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Umeå University:
Stroke
Massage
General Health
Independence

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 18, 2014