Backwards Walking Programme Following Hip and Knee Arthroplasty

Sponsor
Oxford University Hospitals NHS Trust (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04247802
Collaborator
(none)
63
2
2
28.8
31.5
1.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Backwards Walking (BW) programme
  • Other: Usual Care
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Backwards Walking Programme Following Hip and Knee Arthroplasty: A Feasibility Pilot Study
Actual Study Start Date :
Aug 5, 2020
Actual Primary Completion Date :
Oct 15, 2021
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Berg Balance Scale [12 weeks]

    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

  1. Four Square Step Test [12 weeks]

    Objective measure of stepping speed and obstacle clearance in multiple directions

  2. 2 minute walk test [12 weeks]

    Provides a measure of gait speed and distance

  3. 30 second chair raise test [12 weeks]

    Validated clinical measure of lower body strength and dynamic balance

  4. Activities-Specific Balance Confidence Scale [12 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Horton General Hospital Banbury Oxfordshire United Kingdom OX16 9AL
2 Nuffield Orthopaedic Centre Oxford Oxfordshire United Kingdom OX3 7HE

Sponsors and Collaborators

  • Oxford University Hospitals NHS Trust

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Martha Batting, Primary Investigator, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT04247802
Other Study ID Numbers:
  • PID14748
  • 272567
First Posted:
Jan 30, 2020
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022