Clinical trial NCT01883947: Effects of Touch Massage in the Sub-acute Phase After Stroke
Official title: Touch Massage in the Sub-acute Phase After Stroke - Does it Have Impact on General Health and Independence?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Massage
General Health
Independence
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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 criteria: 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.

Primary outcomes:
measure: State-Trait Anxiety Scale
timeFrame: 2 month
Secondary outcomes:
measure: VAS
timeFrame: 2 weeks
measure: Nottingham Health Profile
timeFrame: 2 weeks
measure: ECG
timeFrame: 2 weeks
measure: Salivary cortisol
timeFrame: 2 weeks
measure: Blood pressure
timeFrame: 2 weeks
measure: Shape Texture Identification Test
timeFrame: 2 month
measure: Box and Blocks
timeFrame: 2 month
measure: Nine Hole Peg
timeFrame: 2 month
measure: Jamar® Hydraulic Hand Dynamometer
timeFrame: 2 month
measure: movement laboratory with high-speed cameras
timeFrame: 2 month
measure: Functional magnetic resonance imaging
timeFrame: 2 weeks
measure: Barthel index and Modified Ranking scale
timeFrame: 2 month
Other outcomes:
Locations:
city: Umea
country: Sweden
facility: Norrlands university hospital
Study officials:
affiliation: Umea University
name: Kristina Lämås, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lamas K, Hager 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.