SWIFT Cast: efficacy and neural-biomechanical correlates of response
| ISRCTN | ISRCTN39201286 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39201286 |
| Protocol serial number | EME 08/43/25 |
| Sponsor | University of East Anglia (UK) |
| Funder | Medical Research Council (MRC)/National Institutes of Health Research (NIHR) (UK) - Efficacy and Mechanism Evaluation (EME) Programme (ref: EME 08/43/25) |
- Submission date
- 22/04/2010
- Registration date
- 18/05/2010
- Last edited
- 05/12/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Queens Building
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised controlled observer-blind phase II trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Clinical efficacy of the Soft-Scotch Walking Initial FooT (SWIFT) Cast on walking recovery early after stroke and the neural-biomechanical correlates of response |
| Study acronym | SWIFT Cast |
| Study objectives | The primary driver for this research is the clinical hypothesis, generated by our pilot work, that an individualised and rapidly produced ankle-foot cast (SWIFT CAST) used in addition to protocol-driven conventional physical therapy (CPT) early after stroke is more cost-effective than protocol-driven CPT alone for walking recovery. The scientific premise driving this research is that detailed understanding of how the central nervous system recovers after stroke will enable physical therapies to be targeted at recovery mechanisms in those stroke survivors most likely to respond. Progress is hampered as the predominant means of investigation, functional magnetic resonance imaging (fMRI), has technological limitations and physical therapies used to investigate the central nervous system have been poorly defined. Neuro-biomechanics together with well-defined physical therapies provides a novel way forward. This research will determine clinical efficacy of a SWIFT CAST, as a precursor to a subsequent phase III trial, and use this and protocol-driven CPT to investigate neuro-biomechanical correlates of clinical improvement. Specific questions are: 1. Does the use of a SWIFT CAST provided as an adjunct to CPT enhance walking recovery early after stroke more than CPT given alone? (clinical efficacy) 2. What are the biomechanical correlates of clinical improvement in walking in response to SWIFT CAST and protocol-driven CPT? (understanding biological and behavioural mechanisms) 3. Is site of stroke lesion (structural MR) and/or biomechanical characteristics sufficiently predictive of improvement in walking to enable targeting therapy at stroke survivors likely to respond? (new scientific and clinical principles) In addition, the combination of structural imaging, biomechanics and protocol-driven physical therapy is a novel combination in stroke rehabilitation research and we are therefore also asking: 4. Should neuro-biomechanics and protocol-driven physical therapy be used together with structural neuroimaging to enhance knowledge generated by stroke rehabilitation research? (development/testing of new methodologies) Link to EME project website: http://www.eme.ac.uk/projectfiles/084325info.pdf Link to protocol: http://www.eme.ac.uk/projectfiles/084325protocol.pdf On 15/08/2013 the anticipated end date was changed from 01/09/2013 to 01/12/2012. |
| Ethics approval(s) | Norfolk Research Ethics Committee approved on the 24th December 2009 (ref: 09/H0310/87) |
| Health condition(s) or problem(s) studied | Stroke |
| Intervention | After completion of baseline measurements the intervention phase will last for six weeks. All participants will receive conventional physical therapy (CPT) deemed appropriate for their presentation by the clinical physiotherapists using a standardised treatment schedule. The treatment schedule consists of a recording form and explanatory manual describing the treatment and we have used this successfully with clinical physiotherapists in our recently completed trials comparing CPT and functional strength training for the upper limb and lower limb. The clinical physiotherapists providing CPT will be trained to use the treatment schedule and will document content and amount of treatment provided each day. The records of treatment provided for all participants will be collected by Research Physiotherapists each week. Control intervention: Participants allocated to the control group will receive CPT. A SWIFT CAST will not be provided. They will, however, have a video analysis of their gait (described in experimental intervention) to ensure that assessment is exactly the same as in the experimental group. If participants discontinue CPT before the end of the 6-week intervention period then every effort will be made to include individuals in the outcome and follow-up measures (intention to treat principle). Experimental intervention: Participants allocated to the experimental group will receive a soft-scotch ankle-foot cast (SWIFT Cast) in addition to CPT. A SWIFT Cast is a lightweight, semi-rigid cast extending from the metatarsal heads to the head of the fibula. It positions the paretic foot in relation to the shank so that plantarflexion and/or excessive pronation/supination of the foot is minimised during walking so that the ground reaction force vector assumes the normal direction: passing in front of the knee at floor contact, through the knee in mid-stance and behind the knee in terminal stance. It is made from Soft Cast and Scotch (3M PLC UK). The SWIFT Cast is lightweight (100 - 200 g), semi-rigid and porous. |
| Intervention type | Other |
| Primary outcome measure(s) |
Walking speed: during walking forwards in a straight line at participant-selected speed. Each participant will be asked to undertake 4 walks. Walking speed will be measured in the middle of the walkway using 2 inexpensive infra-red light beams placed 3 metres apart on shoulder-high stands and connected to an electronic timer. Subjects who cannot walk without support, i.e. a FAC score of 2 or less (support of 1 person), will be deemed to have a walking speed of zero. |
| Key secondary outcome measure(s) |
Ability to walk independently, functional mobility, ability to walk with a normal gait pattern and structural brain imaging: |
| Completion date | 01/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 120 |
| Key inclusion criteria | Participants will be recruited from in-patient stroke services and will be followed up until 6 months after stroke wherever they are living. Study criteria are: 1. Aged 18+ years (either sex), 3 - 42 days after stroke, infarct or haemorrhage, confirmed through routine clinical imaging 2. Fit for rehabilitation, i.e., peripheral oxygen saturations 90%+ on air, resting pulse less than 101 beats/minute 3. Walking ability from FAC score 1 to FAC score 5 (section 5) but with: 3.1. Abnormal initial floor contact, and/or 3.2. Impaired ability to take full body weight through the paretic lower limb in stance 4. No contractures at hip, knee, ankle or forefoot or loss of skin integrity over the paretic foot or lower limb. Contracture is defined as persistent loss of full passive range of motion at a joint resulting from structural changes in connective tissues and measured using manual goniometry using the non-paretic lower limb as the comparator. 5. Can follow a 1-stage command, i.e., sufficient communication/orientation for interventions in this trial |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/06/2010 |
| Date of final enrolment | 01/12/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
NR4 7TJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2016 | Yes | No | |
| Protocol article | protocol | 01/01/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/12/2017: internal review.
15/12/2015: Publication references added.