Condition category
Musculoskeletal Diseases
Date applied
01/03/2001
Date assigned
01/03/2001
Last edited
13/09/2016
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 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 measures

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

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

http://www.action.org.uk/

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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