Backwards Walking Programme Following Hip and Knee Arthroplasty

NCT04247802 | Completed Results

• 2 other identifiers: PID14748272567
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Hip Osteoarthritis; Knee Osteoarthritis; Hip Arthroplasty; Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (4)

• Four Square Step Test

  12 weeks

• The Two Minute Walk Test (2MWT)

  12 weeks

• 30 Second Sit to Stand Test

  12 weeks

• Activities-Specific Balance Confidence Scale

  12 weeks

Study Arms (2)

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.

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.

Other: Usual Care

Interventions

Backwards Walking (BW) programme OTHER

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

Backwards Walking (BW) programme

Usual Care OTHER

A 12 week physiotherapy exercise programme EXCLUDING backwards walking

Usual Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (2)

Horton General Hospital

Banbury, Oxfordshire, OX16 9AL, United Kingdom

Location

Nuffield Orthopaedic Centre

Oxford, Oxfordshire, OX3 7HE, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Mrs Martha Batting
• Organization: Oxford University Hospitals NHS Foundation Trust

martha.batting@ouh.nhs.uk

01865

Study Officials

• Martha Batting

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 30, 2020
• Study Start: August 5, 2020
• Primary Completion: October 15, 2021
• Study Completion: December 31, 2021
• Last Updated: January 10, 2025
• Results First Posted: January 10, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)