Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
10/03/2016
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

Dr BB Bhakta

ORCID ID

Contact details

Rheumatology and Rehabilitation Research Unit
36 Clarendon Road
Leeds
LS2 9LN
United Kingdom
+44 (0)113 233 4939
b.bhakta@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436118143

Study information

Scientific title

Development of an intelligent robotic system to aid physical therapy in stroke (development of an arm exerciser that can add to the treatment given by a physiotherapist for people who have had stroke)

Acronym

Study hypothesis

In people with severe arm paresis after stroke, functional recovery in the affected arm is poor. There is some evidence for a beneficial effect of physical therapy on recovery of the arm with a positive dose response relationship.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Paresis after stroke

Intervention

Randomised controlled trial. Random allocation to:
1. Physical therapy
2. Physical therapy with robotic arm exerciser

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Range of voluntary movement
2. Smoothness of movement
3. Arm function

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2002

Overall trial end date

01/05/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Stroke patients with arm paresis and/or spasticity impeding voluntary movement.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/02/2002

Recruitment end date

01/05/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Rheumatology and Rehabilitation Research Unit
Leeds
LS2 9LN
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

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

10/03/2016: No publications found, study status unverified.