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Backwards Walking Programme Following Hip and Knee Arthroplasty

Primary Purpose

Hip Osteoarthritis, Knee Osteoarthritis, Hip Arthroplasty

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Backwards Walking (BW) programme
Usual Care
Sponsored by
Oxford University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Horton General Hospital
  • Nuffield Orthopaedic Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Backwards Walking (BW) programme

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Four Square Step Test
Objective measure of stepping speed and obstacle clearance in multiple directions
2 minute walk test
Provides a measure of gait speed and distance
30 second chair raise test
Validated clinical measure of lower body strength and dynamic balance
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.

Full Information

First Posted
January 28, 2020
Last Updated
November 2, 2022
Sponsor
Oxford University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04247802
Brief Title
Backwards Walking Programme Following Hip and Knee Arthroplasty
Official Title
A Backwards Walking Programme Following Hip and Knee Arthroplasty: A Feasibility Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 5, 2020 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oxford University Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Knee Osteoarthritis, Hip Arthroplasty, Knee Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Backwards Walking (BW) programme
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Backwards Walking (BW) programme
Intervention Description
A 12 week Backwards walking programme prescribed by a registered physiotherapist and completed as part of a home exercise programme.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
A 12 week physiotherapy exercise programme EXCLUDING backwards walking
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Four Square Step Test
Description
Objective measure of stepping speed and obstacle clearance in multiple directions
Time Frame
12 weeks
Title
2 minute walk test
Description
Provides a measure of gait speed and distance
Time Frame
12 weeks
Title
30 second chair raise test
Description
Validated clinical measure of lower body strength and dynamic balance
Time Frame
12 weeks
Title
Activities-Specific Balance Confidence Scale
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Batting
Organizational Affiliation
Oxford University Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Horton General Hospital
City
Banbury
State/Province
Oxfordshire
ZIP/Postal Code
OX16 9AL
Country
United Kingdom
Facility Name
Nuffield Orthopaedic Centre
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7HE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Backwards Walking Programme Following Hip and Knee Arthroplasty

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