Hip OsteoarthritisNCT04247802
Backwards Walking Programme Following Hip and Knee Arthroplasty
A study testing Backwards Walking (BW) programme in people with Hip Osteoarthritis and Knee Osteoarthritis, run by Oxford University Hospitals NHS Trust at 2 sites in United Kingdom.
Trial summary
Backwards walking has been shown to improve balance and walking in patients who have knee Osteoarthritis. It is not known if these benefits may also be seen after surgery in patients who have had a hip or knee replacement because of Osteoarthritis. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Osteoarthritis, Knee Osteoarthritis, Hip Arthroplasty
- What is being tested?
- Backwards Walking (BW) programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 5 Aug 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Men and women aged 65 or older.
- Participant is willing and able to give informed consent for participation in the study.
- Participants who have received a primary unilateral hip or knee arthroplasty due to osteoarthritis.
Who cannot join
- Post-operative weight bearing restrictions.
- Post-operative complications such as infection, a deep vein thrombosis or pulmonary embolism, or failure of the wound to heal.
- Inability to undertake a backwards walking programme due to conditions such as severe cardiovascular or pulmonary disease (New York Heart Association III-IV).
- Severe dementia or communication difficulties that would prevent completion of study assessments.
- Any neurological condition.
- Further planned treatment on the same or contralateral hip or knee within the next 6 months.
- Registered as visually impaired.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Horton General Hospital
Banbury, Oxfordshire, OX16 9AL
Nuffield Orthopaedic Centre
Oxford, Oxfordshire, OX3 7HE
About this study
Official title: A Backwards Walking Programme Following Hip and Knee Arthroplasty: A Feasibility Pilot Study
Backwards walking has been shown to improve balance and walking in patients who have knee Osteoarthritis. It is not known if these benefits may also be seen after surgery in patients who have had a hip or knee replacement because of Osteoarthritis. This study will look to see if it is possible to conduct a bigger study into how effective backwards walking may be after joint replacement. Patients who come to the Nuffield Orthopaedic Centre in Oxford for a hip or knee replacement will be invited. They will be placed into one of two groups at random: a group where they have a course of physiotherapy plus a backwards walking programme or a group where they have a course of physiotherapy. The physiotherapy will last for 12 weeks and those who take part will have two study assessments. The first will be before any treatment and patients will complete five measures and also be issued with a simple tick box diary to complete over the 12 weeks. The second assessment will be after the treatment and will involve the same five measures and the diaries will be collected in. Participants at this assessment will also be asked if they would like to take part in an interview for the study. This is to see what the patients thought of the study. During the study the researcher will record things such as how many patients say 'yes' to the study and how many participants drop out of the treatment, to understand if a bigger study could take place.
- Being tested
- Backwards Walking (BW) programme, Usual Care
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Backwards Walking (BW) programmeOther
A 12 week Backwards walking programme prescribed by a registered physiotherapist and completed as part of a home exercise programme.
Usual CareOther
A 12 week physiotherapy exercise programme EXCLUDING backwards walking
| Study group | Role | What they receive |
|---|---|---|
| Backwards Walking (BW) programme | Experimental | This group will undertake a routine course of one to one out-patient physiotherapy which will include a BW programme. The BW programme will be prescribed by a physiotherapist and the participant will carry it out, along with other prescribed exercises, in their own home. Each participant will initially be prescribed a 5 minute BW programme to be completed once a day. The length of the BW programme and intensity will be progressed or regressed as deemed appropriate by the treating clinician with the aim for patients to achieve at least 10 minutes of BW every day of the week. Receives: Other: Backwards Walking (BW) programme |
| Usual Care | Active comparator | This group will undertake a routine course of one to one out-patient physiotherapy over 12 weeks. To allow comparison between the two groups the control group will also have up to four review appointments where their home exercise programme can be progressed or regressed. The physiotherapy treatments will be not be restricted (apart from no BW programme) to allow for a pragmatic approach based on the treating clinician's clinical judgement, however their content will be recorded on treatment logs. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. All the item scores are combined to make a total from a minimum of 0 to a maximum of 56. Scores between 41-56 indicate a low risk of falls, 21-40 a medium risk and, below 20 a high risk of falls.
Measured: 12 weeks
Secondary outcomes (4)
Four Square Step Test
The Four Square Step Test (FSST) is used to assess dynamic stability and co-ordination. It looks at the ability of the subject to step over low objects (walking sticks placed in 'plus' sign position) forward, sideways, and backward in a square pattern clockwise and anticockwise. The subject is timed completing the stepping task as fast as possible without touching the walking sticks.
Measured: 12 weeks
The Two Minute Walk Test (2MWT)
The Two Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity, particularly for those who cannot manage the longer Six Minute Walk Test (6MWT) or 12 Minute Walk Test. The participant is encouraged to walk as fast as they can, safely, without assistance for two minutes and the distance is measured in metres (m)
Measured: 12 weeks
30 Second Sit to Stand Test
The 30 Second Sit to Stand Test is a validated clinical measure of lower body strength and dynamic balance. Also known as 30 Second Chair Stand Test (30CST), the 30 Second Sit to Stand Test is designed for testing leg strength and endurance in older adults. The test measures the number of stands a person can complete in 30 seconds. The range of number of stands are from 0 to over 20.
Measured: 12 weeks
Activities-Specific Balance Confidence Scale
Activities-specific balance confidence (ABC) scale is a structured questionnaire that measures an individual's confidence during ambulatory activities without falling or experiencing a sense of unsteadiness. It consists of 16 questions gauging the individual's confidence while doing specific activities. Scores range for each item from 0 (no confidence) to 100 (completely confident). For the total score all items were added together and divided by 16 to give the average. The following cut-off scores to define level of functioning among active older adults; lower than 50 %: low level of physical functioning; 50-80 %: moderate level of physical functioning; above 80 %: high level of physical functioning.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start5 Aug 2020
- Primary completion15 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martha Batting, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247802
- Sponsor's protocol ID
- PID14748
- Other IDs
- 272567
- Status last verified
- Jan 2024
- First submitted
- 28 Jan 2020
- Last updated
- 10 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Backwards Walking Programme Following Hip and Knee Arthroplasty: A Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT04247802
- Acronym / sponsor ID
- PID14748
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Posted 10 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Backwards walking has been shown to improve balance and walking in patients who have knee Osteoarthritis. It is not known if these benefits may also be seen after surgery in patients who have had a hip or knee replacement because of Osteoarthritis. This study will look to see if it is possible to conduct a bigger study into how effective backwards walking may be after joint replacement. Patients who come to the Nuffield Orthopaedic Centre in Oxford for a hip or knee replacement will be invited. They will be placed into one of two groups at random: a group where they have a course of physiotherapy plus a backwards walking programme or a group where they have a course of physiotherapy. The physiotherapy will last for 12 weeks and those who take part will have two study assessments. The first will be before any treatment and patients will complete five measures and also be issued with a simple tick box diary to complete over the 12 weeks. The second assessment will be after the treatment and will involve the same five measures and the diaries will be collected in. Participants at this assessment will also be asked if they would like to take part in an interview for the study. This is to see what the patients thought of the study. During the study the researcher will record things such as how many patients say 'yes' to the study and how many participants drop out of the treatment, to understand if a bigger study could take place.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Backwards Walking (BW) programme | Experimental | Other: Backwards Walking (BW) programmeThis group will undertake a routine course of one to one out-patient physiotherapy which will include a BW programme. The BW programme will be prescribed by a physiotherapist and the participant will carry it out, along with other prescribed exercises, in their own home. Each participant will initially be prescribed a 5 minute BW programme to be completed once a day. The length of the BW programme and intensity will be progressed or regressed as deemed appropriate by the treating clinician with the aim for patients to achieve at least 10 minutes of BW every day of the week. |
| Usual Care | Active comparator | Other: Usual CareThis group will undertake a routine course of one to one out-patient physiotherapy over 12 weeks. To allow comparison between the two groups the control group will also have up to four review appointments where their home exercise programme can be progressed or regressed. The physiotherapy treatments will be not be restricted (apart from no BW programme) to allow for a pragmatic approach based on the treating clinician's clinical judgement, however their content will be recorded on treatment logs. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Men and women aged 65 or older.
- Participant is willing and able to give informed consent for participation in the study.
- Participants who have received a primary unilateral hip or knee arthroplasty due to osteoarthritis.
Key exclusion criteria (7 listed)
- Post-operative weight bearing restrictions.
- Post-operative complications such as infection, a deep vein thrombosis or pulmonary embolism, or failure of the wound to heal.
- Inability to undertake a backwards walking programme due to conditions such as severe cardiovascular or pulmonary disease (New York Heart Association III-IV).
- Severe dementia or communication difficulties that would prevent completion of study assessments.
- Any neurological condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Backwards Walking (BW) programmeA 12 week Backwards walking programme prescribed by a registered physiotherapist and completed as part of a home exercise programme. | Other | Backwards Walking (BW) programme |
| Usual CareA 12 week physiotherapy exercise programme EXCLUDING backwards walking | Other | Usual Care |
Primary outcome
Berg Balance Scale
Time frame: 12 weeks
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. All the item scores are combined to make a total from a minimum of 0 to a maximum of 56. Scores between 41-56 indicate a low risk of falls, 21-40 a medium risk and, below 20 a high risk of falls.
4 secondary outcomes
Four Square Step Test
Time frame: 12 weeks
The Two Minute Walk Test (2MWT)
Time frame: 12 weeks
30 Second Sit to Stand Test
Time frame: 12 weeks
Activities-Specific Balance Confidence Scale
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Batting principal investigator
Oxford University Hospitals NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Backwards Walking (BW) programme in people with Hip Osteoarthritis and Knee Osteoarthritis, run by Oxford University Hospitals NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.