Effect of combined somatosensory stimulation and task specific training on upper limb function in chronic stroke patients

Completed

Conditions: Topic: Stroke Research Network
Subtopic: Rehabilitation
Stroke
Disease: Therapy type
Circulatory System

Registration Number: ISRCTN05542931

Lead Sponsor: Kings College London (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 52

Inclusion Criteria

1. At least 65 years of age, either sex
2. History of a single ischaemic stroke at least 3 months duration
3. Abbreviated Mental Test Score (AMT) greater than 7
4. Ambulant and able to attend the laboratory
5. Active range of shoulder elevation at least 60 degrees and 10 degrees of wrist extension
6. Passive pain free range of movement (ROM) of at least 75 % of normal in shoulder, elbow, wrist and hand
7.Presence of motor evoked potential (MEPs) in the hand muscles in response to TMS

Exclusion Criteria

1. Currently undergoing a stroke rehabilitation programme
2. Neurologic disorders or infarcts in the vertebrobasilar territory
3. Severe heart or lung disease
4. Severe aphasia (normal score on the Frenchay Aphasia Screening Test)
5. Visuospatial disorders (as screened by the Star cancellation test)
6. Metal in the head, seizures, auditory or cardiac implants, severe spasticity (defined as a score of greater than 3 on the Modified Ashworth Scale [MAS])

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in functional ability of the upper limb arm. Outcome measures will be assessed at beginning and end of the intervention (duration: 4 weeks) and then at 3 and 6 months follow up. A retest will be made within a week of the initial assessment and before the first treatment session in order to establish the stability of the baseline.

Secondary Outcome Measures

Name	Time	Method
1. Level of dependence in basic activities of daily living (Barthel Index)<br>2. Hand dexterity by the Block and Block test<br>3. Real life use of upper limb (Motor Activity Log)<br>4. Assessment of motor function by the upper limb motor function (FuglMeyer<br>Motor Assessment)<br>5. Health related quality of life (36-item Short Form [SF36])<br>6. Changes in upper limb movement trajectory by 3D motion analysis of upper limb funtion<br>7. Upper limb spasticity by the Modified Ashworth Scale and Tardieu Scale<br><br>Outcome measures will be assessed at beginning and end of the intervention (duration: 4 weeks) and then at 3 and 6 months follow up. A retest will be made within a week of the initial assessment and before the first treatment session in order to establish the stability of the baseline.