|
ISRCTN
|
ISRCTN72463123
|
|
DOI
|
10.1186/ISRCTN72463123
|
|
ClinicalTrials.gov identifier
|
|
|
EudraCT number
|
|
|
Public title
|
Clinical trial to compare electrical stimulation and the conventional ankle-foot orthosis (AFO) in the treatment of dropped foot following stroke
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
AP0770
|
|
Study hypothesis
|
To compare functional electrical stimulation (FES) with ankle foot orthosis (AFO) in the treatment of dropped foot following stroke. The conventional AFO is cheaper, easier to apply than FES and provides consistent and stable support. However, FES allows more passive and active movement of the ankle than the conventional AFO.
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Foot drop
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
01/01/1998
|
|
Anticipated end date
|
31/12/2000
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
22
|
|
Interventions
|
1. One group treated with AFO
2. Second group with electrical stimulation
|
|
Primary outcome measure(s)
|
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 measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Action Medical Research (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Philip
Wright
|
|
Address
|
Department of Medical Physics and Biomedical Engineering
Salisbury District Hospital
|
|
City/town
|
Salisbury
|
|
Zip/Postcode
|
SP2 8BJ
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1722 336 262 ext 4686
|
|
Email
|
p.wright@salisburyfes.com
|
|
Sponsor
|
Action Medical Research (UK)
|
|
Address
|
Vincent House
|
|
City/town
|
Horsham West Sussex
|
|
Zip/Postcode
|
RH12 2DP
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1403 210 406
|
|
Fax
|
+44 (0)1403 210 541
|
|
Email
|
info@actionresearch.co.uk
|
|
Sponsor website:
|
http://www.action.org.uk/
|
|
Date applied
|
01/03/2001
|
|
Last edited
|
04/11/2010
|
|
Date ISRCTN assigned
|
01/03/2001
|
