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Completed

NCT Number: NCT04247802

Backwards Walking Programme Following Hip and Knee Arthroplasty

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Horton General Hospital, Banbury, Oxfordshire, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Backwards Walking (BW) programme

Other

A 12 week Backwards walking programme prescribed by a registered physiotherapist and completed as part of a home exercise programme.

Usual Care

Other

A 12 week physiotherapy exercise programme EXCLUDING backwards walking

Primary outcomes

  1. Berg Balance Scale

    Time frame: 12 weeks

    The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. All the item scores are combined to make a total from a minimum of 0 to a maximum of 56. Scores between 41-56 indicate a low risk of falls, 21-40 a medium risk and, below 20 a high risk of falls.

Secondary outcomes

  1. Four Square Step Test

    Time frame: 12 weeks

    The Four Square Step Test (FSST) is used to assess dynamic stability and co-ordination. It looks at the ability of the subject to step over low objects (walking sticks placed in 'plus' sign position) forward, sideways, and backward in a square pattern clockwise and anticockwise. The subject is timed completing the stepping task as fast as possible without touching the walking sticks.

  2. The Two Minute Walk Test (2MWT)

    Time frame: 12 weeks

    The Two Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity, particularly for those who cannot manage the longer Six Minute Walk Test (6MWT) or 12 Minute Walk Test. The participant is encouraged to walk as fast as they can, safely, without assistance for two minutes and the distance is measured in metres (m)

  3. 30 Second Sit to Stand Test

    Time frame: 12 weeks

    The 30 Second Sit to Stand Test is a validated clinical measure of lower body strength and dynamic balance. Also known as 30 Second Chair Stand Test (30CST), the 30 Second Sit to Stand Test is designed for testing leg strength and endurance in older adults. The test measures the number of stands a person can complete in 30 seconds. The range of number of stands are from 0 to over 20.

  4. Activities-Specific Balance Confidence Scale

    Time frame: 12 weeks

    Activities-specific balance confidence (ABC) scale is a structured questionnaire that measures an individual's confidence during ambulatory activities without falling or experiencing a sense of unsteadiness. It consists of 16 questions gauging the individual's confidence while doing specific activities. 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. The following cut-off scores to define level of functioning among active older adults; lower than 50 %: low level of physical functioning; 50-80 %: moderate level of physical functioning; above 80 %: high level of physical functioning.

Sponsors and collaborators

Lead sponsor

Oxford University Hospitals NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 30, 2020
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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