Contact information
Type
Scientific
Primary contact
Dr Philip Wright
ORCID ID
Contact details
Department of Medical Physics and Biomedical Engineering
Salisbury District Hospital
Salisbury
SP2 8BJ
United Kingdom
+44 (0)1722 336 262 ext 4686
p.wright@salisburyfes.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AP0770
Study information
Scientific title
Clinical trial to compare electrical stimulation and the conventional ankle-foot orthosis (AFO) in the treatment of dropped foot following stroke
Acronym
Study hypothesis
The aim of this study is to compare functional electrical stimulation (FES) with ankle foot orthosis (AFO) in the treatment of dropped foot following stroke.
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
Foot drop
Intervention
1. One group treated with AFO
2. Second group with electrical stimulation
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Walking speed (measured over 10 metres and timed by a stopwatch)
2. Physiological Cost Index (PCI)
3. Endurance (the total distance the participant is able to walk without an AFO or FES in 3 minutes)
4. Calf spasticity (measured using the modified Ashworth Scale)
5. Mobility (measured using the Rivermead Mobility Index)
Outcome measures were taken every six weeks.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1998
Overall trial end date
31/12/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Single stroke of vascular origin in the last 6 months
2. Inadequate dorsiflexion during the swing phase of gait
3. May be a candidate for ankle-foot orthosis (AFO)
4. Able to walk 10 m
5. Willing to participate
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
22
Participant exclusion criteria
1. Previous use of a dropped foot stimulator or AFO in four weeks prior to start of intervention
2. Required an AFO other than that selected for the trial
Recruitment start date
01/01/1998
Recruitment end date
31/12/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Medical Physics and Biomedical Engineering
Salisbury
SP2 8BJ
United Kingdom
Sponsor information
Organisation
Action Medical Research (UK)
Sponsor details
Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Action Medical Research (UK)
Alternative name(s)
AMR
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
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
Basic results (scientific)
Publication list