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

May 27, 2013
August 30, 2013
January 2013
December 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01883947 on ClinicalTrials.gov Archive Site
  • 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
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2016
December 2015   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact: Kristina Lämås, PhD +46907869121 kristina.lamas@umu.se
Sweden
 
NCT01883947
2012-494-32M
Yes
Kristina Lämås, Umeå University
Umeå University
Not Provided
Not Provided
Umeå University
August 2013

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