Upper limb retraining in stroke

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 design	Single-centre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Study objectives	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(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) studied	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
Primary outcome measure	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 study start date	16/06/2009
Completion date	01/06/2011

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	Planned sample size: 100; UK sample size: 100
Key inclusion criteria	1. Confirmed stroke 2. Capable of giving informed consent 3. One hundred consecutive stroke patients (all ages, either sex)
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	16/06/2009
Date of final enrolment	01/06/2011

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"	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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

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