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

ISRCTN ISRCTN05542931
DOI https://doi.org/10.1186/ISRCTN05542931
Protocol serial number 7835
Sponsor Kings College London (UK)
Funder Dunhill Medical Trust (UK)
Submission date
12/05/2010
Registration date
12/05/2010
Last edited
08/05/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jeroen Bergmann
Scientific

Kings College London
Strand
London
WC2R 2LS
United Kingdom

Study information

Primary study designInterventional
Study designSingle centre randomised interventional treatment trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleEffect of combined somatosensory stimulation and task specific training on upper limb function in chronic stroke patients: a double blind randomised controlled trial
Study acronymSensory Stimulation
Study objectivesBackground:
After rehabilitation following a stroke many people recover the ability to walk without assistance, but are very limited in the activities of daily life because of poor recovery in their arm and hand. This loss of function may affect them and their carers and increase their dependency on health and social services. Recent research in both healthy and stroke subjects has indicated that low intensity electrical stimulation of the nerves in the arm, just strong enough to be felt, can lead to changes in the brain and its connection to the stimulated muscles with a resultant improvement in functional performance.

Aims:
We want to investigate whether this type of stimulation in combination with specific exercise training is better than exercises alone (the current clinical practice) for improving arm function and usage in stroke patients who have stopped improving with rehabilitation.

Subjects and methods:
We will carry out a double blind randomised controlled trial. We will recruit people aged 65 years and above who have had a stroke at least three months previously, and are not currently receiving rehabilitation, able to understand instructions and give consent for the study. Subjects will be randomly allocated to two groups to receive either of two packaged interventions. The intervention will take place three times weekly for four weeks at our laboratory located near London Bridge. We will also explore how the stimulation works using techniques which explore brain and movement function.

Outcome measures:
Several arm function tests such as task performance, strength etc in addition to brain function measurements will be assessed at the beginning, immediately after the training and for 6 months after the training at 3-monthly intervals.
Ethics approval(s)Guy's Research Ethics Committee approved on the 27th October 2009 (ref: 09/H0804/87)
Health condition(s) or problem(s) studiedTopic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Therapy type
InterventionSomatosensory 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) in the upper arm using three pairs of self adhesive electrodes (2.5 cm by 2.5 cm). It will be delivered in the laboratory for 2 hours, 3 times each week for 4 weeks using the following dose: 1 ms pulses at 10 Hz, 500 ms on and off. The amplitude will be approximately 3 times feeling threshold.
Intervention typeOther
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

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.

Completion date30/09/2012

Eligibility

Participant type(s)Patient
Age groupSenior
SexAll
Target sample size at registration52
Key inclusion criteria1. 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
Key exclusion criteria1. 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])
Date of first enrolment01/10/2009
Date of final enrolment30/09/2012

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Kings College London
London
WC2R 2LS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2015 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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