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?

Sponsors

Lead Sponsor: Umeå University

Source Umeå University
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.

Overall Status Terminated
Start Date January 2013
Completion Date June 2018
Primary Completion Date June 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
State-Trait Anxiety Scale 2 month
Secondary Outcome
Measure Time Frame
VAS 2 weeks
Nottingham Health Profile 2 weeks
ECG 2 weeks
Salivary cortisol 2 weeks
Blood pressure 2 weeks
Shape Texture Identification Test 2 month
Box and Blocks 2 month
Nine Hole Peg 2 month
Jamar® Hydraulic Hand Dynamometer 2 month
movement laboratory with high-speed cameras 2 month
Functional magnetic resonance imaging 2 weeks
Barthel index and Modified Ranking scale 2 month
Enrollment 50
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Touch massage

Description: 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

Arm Group Label: Touch massage

Intervention Type: Other

Intervention Name: non-TENS

Description: 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.

Arm Group Label: non-TENS

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.

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Kristina Lämås, PhD Principal Investigator Umea University
Location
Facility: Norrlands university hospital
Location Countries

Sweden

Verification Date

June 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Umeå University

Investigator Full Name: Kristina Lämås

Investigator Title: PhD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Touch massage

Type: Experimental

Description: 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

Label: non-TENS

Type: Sham Comparator

Description: 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

Acronym MEST
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov