Condition category
Circulatory System
Date applied
28/05/2010
Date assigned
28/05/2010
Last edited
01/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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
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

Following stroke 30% patients have persistent motor deficits. There is growing evidence that augmenting exercise therapy time after stroke improves outcome. In practice, increasing therapy time demands costly increases in staffing. Robotic aids can provide high-intensity, repetitive, task-specific, interactive treatment of the impaired upper limb.

Aim:
To conduct a feasibility study of use of a cheap, portable, robotic aid for delivering repetitive practice of reach, supination and manipulation.

Methods:
Examination of 100 consecutive patients to establish the proportion of acute stroke patients could potentially benefit from rehabilitation using an aid.

Study outputs:
At the end of the study we will have identified the proportion of stroke patients who can use this robotic aid and the resource implications, the most responsive functional measure and the size of an appropriately powered control trial.

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

Publication citations

Additional files

Editorial Notes