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
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