Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7835
Study information
Scientific title
Effect of combined somatosensory stimulation and task specific training on upper limb function in chronic stroke patients: a double blind randomised controlled trial
Acronym
Sensory Stimulation
Study hypothesis
Background:
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
Guy's Research Ethics Committee approved on the 27th October 2009 (ref: 09/H0804/87)
Study design
Single centre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Therapy type
Intervention
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) 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 type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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
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.
Overall trial start date
01/10/2009
Overall trial end date
30/09/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Planned sample size: 52; UK sample size: 52
Participant 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])
Recruitment start date
01/10/2009
Recruitment end date
30/09/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Kings College London
London
WC2R 2LS
United Kingdom
Sponsor information
Organisation
Kings College London (UK)
Sponsor details
School of Social Sciences and Public Policy
London
WC2R 2LS
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Dunhill Medical Trust (UK)
Alternative name(s)
DMT
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24803495
Publication citations
-
Results
Fleming MK, Sorinola IO, Roberts-Lewis SF, Wolfe CD, Wellwood I, Newham DJ, The Effect of Combined Somatosensory Stimulation and Task-Specific Training on Upper Limb Function in Chronic Stroke: A Double-Blind Randomized Controlled Trial., Neurorehabil Neural Repair, 2014, doi: 10.1177/1545968314533613.