An interventional study of Touch massage and non-TENS in Stroke, sponsored by Umeå University. Terminated at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2019-06-18.
Sponsored by Umeå University · Not applicable, Interventional, and Supportive care
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.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 50 is close to the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Umeå University is the lead sponsor of 271 studies on the registry; 60 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:individuals with
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
Procedure: Touch massage
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
Other: non-TENS
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
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.
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
Time frame: 2 month
VAS
To assess self-rated pain
Time frame: 2 weeks
Nottingham Health Profile
This is a self-rating scale which assess Health related quality of life
Time frame: 2 weeks
ECG
evaluate heart rate variability which reflects activity in the autonomic nervous system
Time frame: 2 weeks
Salivary cortisol
To assess effects on stress responses
Time frame: 2 weeks
Blood pressure
to assess effects on stress responses
Time frame: 2 weeks
Shape Texture Identification Test
will be used to assess touch discrimination
Time frame: 2 month
Box and Blocks
will be used to test gross dexterity
Time frame: 2 month
Nine Hole Peg
will be used to test fine motor dexterity,
Time frame: 2 month
Jamar® Hydraulic Hand Dynamometer
will be used to assess grip strength
Time frame: 2 month
movement laboratory with high-speed cameras
Temporal and spatial kinematic variables will be evaluated
Time frame: 2 month
Functional magnetic resonance imaging
Evaluation of brain activity while patient perform finger-tapping/movement with the paretic hand
Time frame: 2 weeks
Barthel index and Modified Ranking scale
will be used to assess disability after stroke
Time frame: 2 month
Plan to share: No
The record gives a start of Jan 2013, a primary completion of Jun 2017 and a completion of Jun 2018. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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