An observational study of physiotherapy practice to determine essential processes in the assessment of walking, standing and rising from a chair in patients with stroke and in older people with musculoskeletal impairments
| ISRCTN | ISRCTN16707229 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16707229 |
| IRAS number | 264069 |
| Secondary identifying numbers | IRAS 264069 |
- Submission date
- 17/07/2020
- Registration date
- 14/08/2020
- Last edited
- 12/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Nearly 6.5 million in the UK have mobility impairments. The largest causes of impairment are age-related changes (40% of over-60s have disabilities affecting their daily lives) and stroke (there are over 1.2 million stroke survivors in the UK). These numbers are growing as the population age increases and age-related mobility issues dominate. The increasing need for effective rehabilitation may in part be addressed by the development of new devices that will enable more targeted and personalised practice of mobility tasks.
This study is the first study as part of the FREEHAB project, which aims to observe physiotherapy practice and patients’ performance to inform the design of wearable devices to assist in the rehabilitation of mobility. The questions the study addresses are:
1. How do physiotherapists assess and analyse a patient’s movement to determine treatment plans to improve the performance of mobility tasks?
2. What are the common features of assessment, analysis and task-specific training for walking, standing and getting up from a chair?
3. What are the essential components of the assessment and movement analysis process that will be needed in the design specification of rehabilitation devices?
The study’s objectives are to:
1. Capture a video of physiotherapists’ assessment of patients, while the therapists are talking aloud about their diagnostic process.
2. Capture quantitative clinical measures of strength, range of motion and functional performance from patient participants (outside of the therapist’s assessment process).
3. Capture biomechanical analysis of patient participant’s performance.
4. Map results from physiotherapy assessment with clinical and biomechanical measures.
5. Determine the essential components of the assessment and movement analysis process that will be needed in the design specification of devices.
Who can participate?
Physiotherapists working in clinical partner organisations with stroke or older patients to improve their mobility
Patients being seen by a physiotherapist in the clinical partner service for rehabilitation of mobility who have had a diagnosis of stroke with hemiparesis* or are an older patient (over 65) with weakness following musculoskeletal impairment (for example after joint replacement)
* Note - Time after stroke is not limited and participants may have had multiple strokes. Potential participants with poor balance, sensory loss, visual field loss aphasia and cognitive impairments but who have the capacity to consent can be accommodated.
What does the study involve?
Physiotherapists’ actions and clinical reasoning during their assessment of their patients’ functional mobility will be video recorded and analysed. Quantitative clinical measures and patient participants' biomechanics during movement of interest will be collected. The analysis will determine the essential components of movement assessment, and the context of the therapists’ reasoning and actions. Discussion of the findings with clinical partners will inform the design for the rehabilitative devices to be developed.
What are the possible benefits and risks of participating?
Physiotherapists will be able to reflect on their practice and have the opportunity to experience research, which can be recorded in their professional portfolio. There are no immediate benefits for the patient participants other than the satisfaction of supporting research. The study is not providing any new intervention or taking anything away from usual care. The potential to cause distress to patient-participants is mitigated by identifying suitable participants via the therapist. Patient participants are at potential risk of falls during data collection due to their musculoskeletal impairments or impairments from stroke, however, this risk is low as there is continuation of patients’ physiotherapists and a UWE researcher who is an HCPC-registered physiotherapist will be collecting biomechanical data. The study will collect outcome measures that are part of an ordinary physiotherapy assessment. There is a potential risk of an allergic reaction to adhesive tapes used for biomechanical analysis, this will be offset by the use of hypoallergenic tape.
Where is the study run from?
This is a Bristol-based study by the University of Bristol in collaboration with the University of the West of England. It involves physiotherapy partners in local NHS Trusts and Community Rehabilitation Services.
When is the study starting and how long is it expected to run for?
November 2019 to October 2023
Who is funding the study?
Engineering and Physical Sciences Research Council (UK)
Who is the main contact?
Jonathan Rossiter
jonathan.rossiter@bristol.ac.uk
Contact information
Public
Bristol Robotics Laboratory
Coldharbour Lane
Frenchay
Filton
Bristol
BS16 1QY
United Kingdom
| Phone | +44 (0)117 3315601 |
|---|---|
| jonathan.rossiter@bristol.ac.uk |
Public
Allied Health Professions, Faculty of Health and Applied Sciences
University of the West of England, Glenside Campus, Blackberry Hill
Bristol
BS16 1DD
United Kingdom
 ORCID ID |
0000-0002-4651-1514 |
|---|---|
| Phone | +44 (0)117 3286908 |
| Leah.Morris@uwe.ac.uk |
Study information
| Study design | Observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | FREEHAB study 1: physiotherapy analysis of functional mobility: walking, standing and transfer in stroke and older people |
| Study acronym | FREEHAB |
| Study objectives | The purpose of this observational study is to determine specifications for end-user cases for improving walking, standing and sit to stand movements. |
| Ethics approval(s) | Approved 27/07/2020, South West Frenchay Research Ethics Committee (Bristol HRA Centre, Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8360, +44 (0)207 104 8041; frenchay.rec@hra.nhs.uk), REC ref: 20/SW/0092 |
| Health condition(s) or problem(s) studied | Diagnosis of stroke with hemiparesis or older patient (over 65 years) with weakness following musculoskeletal impairment (for example post joint replacement or surgery following a fall) |
| Intervention | Physiotherapists’ actions and clinical reasoning during their assessment of their patients’ functional mobility will be video recorded and analysed. Quantitative clinical measures and participants' biomechanics during movement of interest will be collected. The analysis will determine the essential components of movement assessment, and the context of the therapists’ reasoning and actions. Discussion of the findings with clinical partners will enable the establishment of the design envelope for the adaptive rehabilitative devices to be developed in FREEHAB. |
| Intervention type | Other |
| Primary outcome measure | Measured at a single timepoint: 1. Lower limb joint range of motion (passive and active) measured using a digital goniometer 2. Strength of lower limb musculature (ankle dorsiflexion/plantarflexion, knee flexion/extension and hip extension/abduction) measured using a Lafayette Hand-held Dynamometer 3. Functional performance measured using forward functional reach test and timed up and go test 4. Biomechanical measures of pelvic and lower limb motion using three-dimensional motion capture |
| Secondary outcome measures | Collected from patients' medical notes at a single timepoint: 1. Patient's gender, age 2. Reason for admission to service 3. Any relevant pre-existing diagnosis that would affect mobility 4. Information about current clinical condition affecting mobility. In the case of stroke, this will include date of stroke, side of stroke and type of stroke |
| Overall study start date | 04/11/2019 |
| Completion date | 31/10/2023 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | 30 patients, 6 physiotherapists |
| Total final enrolment | 30 |
| Key inclusion criteria | Patients: 1. Diagnosis of stroke with hemiparesis* or older patient (over 65 years) with weakness following musculoskeletal impairment (for example post joint replacement or surgery following a fall) 2. Being seen by a physiotherapist in the clinical partner service for rehabilitation of mobility (standing balance, transfers or walking) 3. Medically stable 4. Mental capacity to consent to the study according to members of the clinical team who are working with the patient * Note - Time after stroke is not limited and potential participants who had had a stroke can still take part if the stroke is not the first stroke. Potential participants with poor balance, sensory loss, visual field loss aphasia and cognitive impairments, but who have capacity to consent can be accommodated Physiotherapists: Physiotherapists who are working in clinical partner organisations with stroke or older patients to improve their mobility |
| Key exclusion criteria | Patients: 1. Diagnosis of neurological condition, other than stroke 2. Concurrent acute musculoskeletal conditions (e.g. fractures, sprains) which prevent weight-bearing 3. Morbidly obese - BMI > 40 kg/m2 4. Presence of ataxia 5. Judged by therapists to have a functional neurological disorder 6. Judged by therapist to have depression or anxiety that might prevent participation, or become increased because of participation in the study Physiotherapists: Less than 2 years’ experience of working with stroke or older patients |
| Date of first enrolment | 04/08/2020 |
| Date of final enrolment | 24/02/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
BS10 5BN
United Kingdom
Bath and North East Somerset
Bath
BA2 5RP
United Kingdom
Bristol and South West
-
United Kingdom
Sponsor information
University/education
1 Cathedral Square
Bristol
BS1 5DD
England
United Kingdom
| Phone | +44 (0)117 9289000 |
|---|---|
| research-governance@bristol.ac.uk | |
| Website | http://bristol.ac.uk/ |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- UKRI Engineering and Physical Sciences Research Council, Engineering and Physical Sciences Research Council - UKRI, Engineering & Physical Sciences Research Council, EPSRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/10/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | Participant level data will be available on the University of the West of England’s research data repository. All data that is made available will be anonymised and will not include video data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 0.3 | 12/01/2021 | 07/11/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
12/11/2024: The intention to publish date was changed from 31/10/2024 to 31/10/2025.
13/09/2023: The following changes were made:
1. The recruitment end date was changed from 30/09/2023 to 24/02/2023.
2. The total final enrolment was added.
07/11/2022: Protocol file uploaded (not peer reviewed).
09/08/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 02/07/2021 to 30/09/2023.
2. The overall end date was changed from 27/05/2022 to 31/10/2023.
3. The intention to publish date was changed from 02/08/2022 to 31/10/2024.
4. The plain English summary was updated to reflect these changes.
12/07/2021: The overall trial end date was changed from 02/08/2021 to 27/05/2022.
14/08/2020: Uploaded protocol Version 0.2, 17 July 2020 (not peer reviewed).
06/08/2020: Trial's existence confirmed by South West Frenchay Research Ethics Committee.
