Clinical trial NCT04247802: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Knee Osteoarthritis
Hip Arthroplasty
Knee Arthroplasty
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 63
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Four Square Step Test
timeFrame: 12 weeks
measure: The Two Minute Walk Test (2MWT)
timeFrame: 12 weeks
measure: 30 Second Sit to Stand Test
timeFrame: 12 weeks
measure: Activities-Specific Balance Confidence Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Banbury
country: United Kingdom
facility: Horton General Hospital
state: Oxfordshire
city: Oxford
country: United Kingdom
facility: Nuffield Orthopaedic Centre
state: Oxfordshire
Study officials:
affiliation: Oxford University Hospitals NHS Trust
name: Martha Batting
role: PRINCIPAL_INVESTIGATOR
References: