Contact information
Type
Scientific
Primary contact
Prof Diane Playford
ORCID ID
Contact details
Multiple Sclerosis and NMR
National Hospital for Neurology and Neurosurgery
Queen Square
London
WC1N 3BG
United Kingdom
+44 20 7837 3611
d.playford@ion.ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7511
Study information
Scientific title
A feasibility study of use of a cheap, portable, robotic aid for delivering repetitive practice of reach, supination and manipulation in acute stroke
Acronym
Study hypothesis
The aim of this study is to conduct a feasibility study of use of a cheap, portable, robotic aid for delivering repetitive practice of reach, supination and manipulation.
Ethics approval
The National Hospital for Neurology and Neurosurgery & Institute of Neurology Joint REC, April 2008, ref: 08/H0716/13
Study design
Single-centre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Device used
Intervention
The study is recruiting the first 100 stroke patients admitted to UCLH trusts. Subjects following consent to participate are to have baseline outcome measures taken. If participants have arm impairments these measures are retaken at 6 weeks or on discharge if earlier. Subjects with arm impairments are also assessed weekly to see if they can interface with a mock up of a robotic device.
Patients will be assessed by a physiotherapist seven days after admission and weekly for the first six weeks or until they are discharged, whichever is the earlier. A final assessment will take place for all patients at six weeks.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Measured seven days after admission, then weekly until 6 weeks:
1. Action Research Arm Test (ARAT)
2. Disabilities of Arm, Shoulder, Hand (DASH)
3. Chedoke Arm and Hand Inventory
4. Measure of manual ability for adults with upper limb impairments (ABILHAND)
5. Stroke Rehabilitation Assessment of Movement (STREAM)
Secondary outcome measures
Measured seven days after admission, then weekly until 6 weeks:
1. Barthel Index
2. European Quality of Life Questionnaire (EQ-5D)
3. 36-item Short Form Health Survey (SF36)
4. National Institutes of Health Stroke Scale (NIHSS)
Overall trial start date
16/06/2009
Overall trial end date
01/06/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Confirmed stroke
2. Capable of giving informed consent
3. One hundred consecutive stroke patients (all ages, either sex)
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Planned sample size: 100; UK sample size: 100
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
16/06/2009
Recruitment end date
01/06/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Multiple Sclerosis and NMR
London
WC1N 3BG
United Kingdom
Sponsor information
Organisation
National Hospital for Neurology and Neurosurgery (UK)
Sponsor details
Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom
Sponsor type
Hospital/treatment centre
Website
http://www.uclh.nhs.uk/Our+hospitals/National+Hospital+for+Neurology+and+Neurosurgery.htm
Funders
Funder type
Charity
Funder name
The Stroke Association (UK) (ref: TSA 2007/14)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Results - basic reporting
Publication summary