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

Stroke Clinical Trial

— MEST  

Official title:

Touch Massage in the Sub-acute Phase After Stroke - Does it Have Impact on General Health and Independence?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01883947
• Other study ID #: 2012-494-32M
• Status: Terminated
• Phase: N/A
• Start date: January 2013
• Est. completion date: June 2018

Study information

• Verified date: June 2019
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: June 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Sweden	Norrlands university hospital	Umea

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State-Trait Anxiety Scale	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	2 month
Secondary	VAS	To assess self-rated pain	2 weeks
Secondary	Nottingham Health Profile	This is a self-rating scale which assess Health related quality of life	2 weeks
Secondary	ECG	evaluate heart rate variability which reflects activity in the autonomic nervous system	2 weeks
Secondary	Salivary cortisol	To assess effects on stress responses	2 weeks
Secondary	Blood pressure	to assess effects on stress responses	2 weeks
Secondary	Shape Texture Identification Test	will be used to assess touch discrimination	2 month
Secondary	Box and Blocks	will be used to test gross dexterity	2 month
Secondary	Nine Hole Peg	will be used to test fine motor dexterity,	2 month
Secondary	Jamar® Hydraulic Hand Dynamometer	will be used to assess grip strength	2 month
Secondary	movement laboratory with high-speed cameras	Temporal and spatial kinematic variables will be evaluated	2 month
Secondary	Functional magnetic resonance imaging	Evaluation of brain activity while patient perform finger-tapping/movement with the paretic hand	2 weeks
Secondary	Barthel index and Modified Ranking scale	will be used to assess disability after stroke	2 month