Clinical trial to compare electrical stimulation and the conventional ankle-foot orthosis (AFO) in the treatment of dropped foot following stroke

ISRCTN	ISRCTN72463123
DOI	https://doi.org/10.1186/ISRCTN72463123
Secondary identifying numbers	AP0770

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Philip Wright
Scientific

Department of Medical Physics and Biomedical Engineering
Salisbury District Hospital
Salisbury
SP2 8BJ
United Kingdom

Phone	+44 (0)1722 336 262 ext 4686
Email	p.wright@salisburyfes.com

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Clinical trial to compare electrical stimulation and the conventional ankle-foot orthosis (AFO) in the treatment of dropped foot following stroke
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Foot drop
Intervention	1. One group treated with AFO 2. Second group with electrical stimulation
Intervention type	Other
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 study start date	01/01/1998
Completion date	31/12/2000

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	22
Key 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
Key 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
Date of first enrolment	01/01/1998
Date of final enrolment	31/12/2000

Department of Medical Physics and Biomedical Engineering

Salisbury
SP2 8BJ
United Kingdom

Action Medical Research (UK)
Charity

Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom

Website	http://www.action.org.uk/
"ROR"	https://ror.org/01wcqa315

Charity

Action Medical Research (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): actionmedres, action medical research for children, AMR
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

13/09/2016: No publications found in PubMed, verifying study status with principal investigator.