Backwards Walking Programme Following Hip and Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

A Backwards Walking Programme Following Hip and Knee Arthroplasty: A Feasibility Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04247802
• Other study ID #: PID14748
• Secondary ID: 272567
• Status: Completed
• Phase: N/A
• Start date: August 5, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Oxford University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 31, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hip Arthroplasty
• Hip Osteoarthritis
• Knee Arthroplasty
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

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.
• Usual Care
A 12 week physiotherapy exercise programme EXCLUDING backwards walking

Locations

Country	Name	City	State
United Kingdom	Horton General Hospital	Banbury	Oxfordshire
United Kingdom	Nuffield Orthopaedic Centre	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Four Square Step Test	Objective measure of stepping speed and obstacle clearance in multiple directions	12 weeks
Secondary	2 minute walk test	Provides a measure of gait speed and distance	12 weeks
Secondary	30 second chair raise test	Validated clinical measure of lower body strength and dynamic balance	12 weeks
Secondary	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