Condition category
Nervous System Diseases
Date applied
22/03/2017
Date assigned
19/04/2017
Last edited
25/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A stroke occurs when the blood supply to the brain is cut off. This can cause long term problems with mobility due to the injury to the brain. A major problem for people who have had a stroke is learning to walk again. Physiotherapy is a type of rehabilitation that helps restore movement and function to patients. Physiotherapists help stroke patients to walk using different types of exercises. Sometimes different equipment, such as using a treadmill, can be used to help patients to walk again. This study looks at the feasibility of using a treadmill and the outcomes of relearning how to walk for people who had had a stroke within the last three months. The main aims of this study is to see if a study like this is feasible, to see how to provide treadmill training for stroke patients, see if using a treadmill can help improve mobility when compared to standard physiotherapy patients and to create a larger study in the future.

Who can participate?
Adults over the age of 18 who have had a stroke.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the standard physiotherapy treatment and gait (walking) training. Those in the second group receive the standard physiotherapy treatment three times a week over eight weeks. They also receive at least two gait training sessions that use a treadmill. After the eight weeks, participants continue with their standard physiotherapy treatments without using a treadmill. Participants are assessed before the treatment, right after the treatment and in a six month follow up to assess their mobility.

What are the possible benefits and risks of participating?
Participants may benefit from improving their mobility, independence and quality of life. There are minimal risks with participating, such as falling during physiotherapy; however participants are given support by physiotherapists to prevent this.
Where is the study run from?
This study is run by Queen Margaret University Edinburgh and takes place in Astley Ainslie Hospital (UK), St Johns Hospital (UK), the Royal Victoria Hospital (UK) and the Liberton Hospital (UK)

When is the study starting and how long is it expected to run for?
October 2005 to December 2008

Who is funding the study?
Chest Heart and Stroke Scotland (UK)

Who is the main contact?
Dr Gillian Baer

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gillian Baer

ORCID ID

Contact details

Physiotherapy
School of Health Sciences
Queen Margaret University
Queen Margaret University Drive
Edinburgh
Edinburgh
EH21 6UU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R06/A99

Study information

Scientific title

Treadmill Training for people with Sub-Acute Stroke: A phase II randomised controlled trial

Acronym

STATT

Study hypothesis

The aim of this pilot study is to evaluate the effects and feasibility of using treadmill training in people with stroke, within the first 3 months after stroke.

Ethics approval

Scotland A Multi-Centre Research Ethics Committee, 16/10/2006, 06/MRE00/82

Study design

Exploratory phase II single-blind feasibility multi-site randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Sub-acute Stroke

Intervention

Participants are randomly allocated to either the intervention group or the control group. Randomisation is done after participants undergo baseline measurements using a computer generated minimisation method. Minimisation takes into account the side of the body that the stroke occurred on and whether the participants are ambulant without physical assistance (using the Functional Ambulation category 4-6) or the participants are non-ambulant or ambulant only with physical assistance (Functional Ambulation category 1-3).

Intervention Group (TT): This intervention occurs over eight weeks (or fewer if the participant is discharged from the unit before the eight weeks). Participants in this group receive at least three treatment sessions per week comprising of normal physiotherapy and gait training. At least two gait training sessions include the treadmill. The actual time on the treadmill is determined by the treating physiotherapist. All the time on the treadmill is recorded. After eight weeks, participants in this group reverted back to normal physiotherapy with no further access to the treadmill.

Control group (CON): This intervention occurs over eight weeks (or fewer if the participant is discharged from the unit before the eight weeks). Participant in this group receive at least three treatment sessions per week comprising of normal physiotherapy and gait training. Gait training has no access to a treadmill. The time for the normal physiotherapy is determined clinically.

Participants are assessed for their mobility at baseline, at the end of the interventions (eight weeks) and at a six month follow up. As this is a feasibility phase II randomised controlled trial, data from a battery of secondary outcome measures are collected.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Mobility is measured using the Rivermead Mobility Index at baseline, eight weeks and six months.

Secondary outcome measures

1. Mobility and balance is measured using the Timed Up and Go (TUG) at baseline, eight weeks and six months
2. Gait speed is measured using a 10 metre walk (10mwt), at baseline, eight weeks and six months
3. Walking endurance is measured using a six minute walk test (6minwt) at baseline, eight weeks and six months
4. Confidence in walking is measured using a vertical 10cm Visual Analogue Scale (VAS), patient interviews and following a standardised operating procedure at baseline, eight weeks and six months
5. Motor impairments and everyday motor function is measured using the Motor Assessment Scale (MAS) at baseline, eight weeks and six months
6. Dependence in Activities of Daily Living is measured using Barthel Index at baseline, eight weeks and six months
7. Self reported recovery and quality of life is measured using the Stroke Impact Scale v3.0 at baseline, eight weeks and six months

Overall trial start date

12/10/2005

Overall trial end date

19/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 18
2. Had a stroke as defined by WHO 1988
3. One minute standing balance (with or without support, this was required to allow donning a safety harness if supported treadmill training was required)
4. Medically stable
5. Within three months of stroke onset
6. Able to understand and follow verbal instructions; and
7. Able to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

target 100

Participant exclusion criteria

1. Co-existing non-stroke related neurological impairments
2. Co-morbidities precluding gait training (e.g. amputee)
3. Non-ambulant prior to stroke
4. Body weight greater than 138kg (Weight limit of equipment)
5. Unsafe to use treadmill
6. Unable to follow simple commands

Recruitment start date

04/05/2007

Recruitment end date

20/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Astley Ainslie Hospital
Physiotherapy 33 Grange Loan
Edinburgh
EH9 2HL
United Kingdom

Trial participating centre

St Johns Hospital
Physiotherapy Howden Road West Howden
Livingston
EH54 6PP
United Kingdom

Trial participating centre

The Royal Victoria Hospital
Physiotherapy 13 Craigleith Road
Edinburgh
EH4 2DN
United Kingdom

Trial participating centre

Liberton Hosptial
Physiotherapy 113 Lasswade Road
Edinburgh
EH16 6UB
United Kingdom

Sponsor information

Organisation

Queen Margaret University

Sponsor details

School of Health Sciences
Queen Margaret University Drive
Edinburgh
EH21 6UU
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Chest Heart and Stroke Scotland

Alternative name(s)

CHSS

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal and dissemination at conferences.

IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Gillian Baer (Principal Investigator) gbaer@qmu.ac.uk

Intention to publish date

31/07/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28730849

Publication citations

Additional files

Editorial Notes

25/09/2017: Internal review. 08/08/2017: Publication reference added. 21/04/2017: The participant information sheet has been uploaded.