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

Effect of combined somatosensory stimulation and task specific training on upper limb function in chronic stroke patients: a double blind randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN05542931
Enrollment
52
Registered
2010-05-12
Start date
2009-10-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Stroke Research Network

Interventions

Somatosensory stimulation will be delivered to three arm nerves (ulnar at the medial epicondylar groove of the elbow, median in front of the elbow joint and radial nerve above the lateral epicondyle)

Sponsors

Kings College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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])

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Level of dependence in basic activities of daily living (Barthel Index) 2. Hand dexterity by the Block and Block test 3. Real life use of upper limb (Motor Activity Log) 4. Assessment of motor function by the upper limb motor function (FuglMeyer Motor Assessment) 5. Health related quality of life (36-item Short Form [SF36]) 6. Changes in upper limb movement trajectory by 3D motion analysis of upper limb funtion 7. Upper limb spasticity by the Modified Ashworth Scale and Tardieu Scale 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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026