Backwards Walking Programme Following Hip and Knee Arthroplasty

NCT ID: NCT04247802

Last Updated: 2025-01-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-05

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hip Osteoarthritis Knee Osteoarthritis Hip Arthroplasty Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Backwards Walking (BW) programme

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.

Group Type EXPERIMENTAL

Backwards Walking (BW) programme

Intervention Type OTHER

A 12 week Backwards walking programme prescribed by a registered physiotherapist and completed as part of a home exercise programme.

Usual Care

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.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

A 12 week physiotherapy exercise programme EXCLUDING backwards walking

Interventions

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Backwards Walking (BW) programme

A 12 week Backwards walking programme prescribed by a registered physiotherapist and completed as part of a home exercise programme.

Intervention Type OTHER

Usual Care

A 12 week physiotherapy exercise programme EXCLUDING backwards walking

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oxford University Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martha Batting

Role: PRINCIPAL_INVESTIGATOR

Oxford University Hospitals NHS Trust

Locations

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Horton General Hospital

Banbury, Oxfordshire, United Kingdom

Site Status

Nuffield Orthopaedic Centre

Oxford, Oxfordshire, United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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272567

Identifier Type: OTHER

Identifier Source: secondary_id

PID14748

Identifier Type: -

Identifier Source: org_study_id

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