Backwards Walking Programme Following Hip and Knee Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Hip Osteoarthritis; Knee Arthroplasty; Hip Arthroplasty
• Intervention / Treatment: Other: Backwards Walking (BW) programme; Other: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Banbury, Oxfordshire, United Kingdom, OX16 9AL
      • Horton General Hospital
    • Oxford, Oxfordshire, United Kingdom, OX3 7HE
      • Nuffield Orthopaedic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: Backwards Walking (BW) programme; A 12 week Backwards walking programme prescribed by a registered physiotherapist and completed as part of a home exercise programme.
ACTIVE_COMPARATOR: 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.	Other: Usual Care; A 12 week physiotherapy exercise programme EXCLUDING backwards walking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale	14-item objective measure of static and dynamic balance. Each item is rated from 0 (low score) to 4 (high score). The test is scored out of 56. Scores between 41-56 indicate low risk of falls, 21-40 medium risk and below 20 high risk of falls.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Four Square Step Test	Objective measure of stepping speed and obstacle clearance in multiple directions	12 weeks
2 minute walk test	Provides a measure of gait speed and distance	12 weeks
30 second chair raise test	Validated clinical measure of lower body strength and dynamic balance	12 weeks
Activities-Specific Balance Confidence Scale	Self-report measure of balance confidence whilst performing 16 different tasks. 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.	12 weeks

Collaborators and Investigators

• Sponsor: Oxford University Hospitals NHS Trust
• Investigators: Principal Investigator: Martha Batting, Oxford University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 5, 2020
• Primary Completion (ACTUAL): October 15, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (ACTUAL): January 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
• Other Study ID Numbers: PID14748; 272567 (OTHER: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No