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

This study is currently recruiting participants.
Verified May 2016 by Kristina Lämås, Umeå University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01883947
First Posted: June 21, 2013
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Kristina Lämås, Umeå University
May 27, 2013
June 21, 2013
May 12, 2016
January 2013
June 2017   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01883947 on ClinicalTrials.gov Archive Site
  • VAS [ Time Frame: 2 weeks ]
    To assess self-rated pain
  • Nottingham Health Profile [ Time Frame: 2 weeks ]
    This is a self-rating scale which assess Health related quality of life
  • ECG [ Time Frame: 2 weeks ]
    evaluate heart rate variability which reflects activity in the autonomic nervous system
  • Salivary cortisol [ Time Frame: 2 weeks ]
    To assess effects on stress responses
  • Blood pressure [ Time Frame: 2 weeks ]
    to assess effects on stress responses
  • Shape Texture Identification Test [ Time Frame: 2 month ]
    will be used to assess touch discrimination
  • Box and Blocks [ Time Frame: 2 month ]
    will be used to test gross dexterity
  • Nine Hole Peg [ Time Frame: 2 month ]
    will be used to test fine motor dexterity,
  • Jamar® Hydraulic Hand Dynamometer [ Time Frame: 2 month ]
    will be used to assess grip strength
  • movement laboratory with high-speed cameras [ Time Frame: 2 month ]
    Temporal and spatial kinematic variables will be evaluated
  • Functional magnetic resonance imaging [ Time Frame: 2 weeks ]
    Evaluation of brain activity while patient perform finger-tapping/movement with the paretic hand
  • Barthel index and Modified Ranking scale [ Time Frame: 2 month ]
    will be used to assess disability after stroke
Same as current
Not Provided
Not Provided
 
Effects of Touch Massage in the Sub-acute Phase After Stroke
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Stroke
  • 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
  • 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.
  • 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
    Intervention: Procedure: Touch massage
  • 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
    Intervention: Other: non-TENS
Lämås K, Häger 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
June 2018
June 2017   (Final data collection date for primary outcome measure)

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: All
Child, Adult, Senior
No
Contact: Kristina Lämås, PhD +46907869121 kristina.lamas@umu.se
Sweden
 
 
NCT01883947
2012-494-32M
Yes
Not Provided
Plan to Share IPD: No
Kristina Lämås, Umeå University
Umeå University
Not Provided
Principal Investigator: Kristina Lämås, PhD Umea University
Umeå University
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP