ISRCTN ISRCTN96487050
DOI https://doi.org/10.1186/ISRCTN96487050
Secondary identifying numbers 7511
Submission date
28/05/2010
Registration date
28/05/2010
Last edited
11/05/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Diane Playford
Scientific

Multiple Sclerosis and NMR
National Hospital for Neurology and Neurosurgery
Queen Square
London
WC1N 3BG
United Kingdom

Phone +44 20 7837 3611
Email d.playford@ion.ucl.ac.uk

Study information

Study designSingle-centre randomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA feasibility study of use of a cheap, portable, robotic aid for delivering repetitive practice of reach, supination and manipulation in acute stroke
Study objectivesThe 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(s)The National Hospital for Neurology and Neurosurgery & Institute of Neurology Joint REC, April 2008, ref: 08/H0716/13
Health condition(s) or problem(s) studiedTopic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Device used
InterventionThe 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 typeOther
Primary outcome measureMeasured 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 measuresMeasured 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 study start date16/06/2009
Completion date01/06/2011

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participantsPlanned sample size: 100; UK sample size: 100
Key inclusion criteria1. Confirmed stroke
2. Capable of giving informed consent
3. One hundred consecutive stroke patients (all ages, either sex)
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment16/06/2009
Date of final enrolment01/06/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Multiple Sclerosis and NMR
London
WC1N 3BG
United Kingdom

Sponsor information

National Hospital for Neurology and Neurosurgery (UK)
Hospital/treatment centre

Institute of Neurology
Queen Square
London
WC1N 3BG
England
United Kingdom

Website http://www.uclh.nhs.uk/Our+hospitals/National+Hospital+for+Neurology+and+Neurosurgery.htm
ROR logo "ROR" https://ror.org/048b34d51

Funders

Funder type

Charity

The Stroke Association (UK) (ref: TSA 2007/14)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

11/05/2017: No publications found in PubMed, verifying study status with principal investigator