Trial Outcomes & Findings for Backwards Walking Programme Following Hip and Knee Arthroplasty (NCT NCT04247802)
NCT ID: NCT04247802
Last Updated: 2025-01-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-01-10
Participant Flow
Participant milestones
| Measure |
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.
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
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.
Usual Care: A 12 week physiotherapy exercise programme EXCLUDING backwards walking
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
30
|
|
Overall Study
COMPLETED
|
22
|
20
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
Reasons for withdrawal
| Measure |
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.
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
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.
Usual Care: A 12 week physiotherapy exercise programme EXCLUDING backwards walking
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
LTFU COVID lockdown restrictions
|
10
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Backwards Walking (BW) Programme
n=33 Participants
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.
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
n=30 Participants
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.
Usual Care: A 12 week physiotherapy exercise programme EXCLUDING backwards walking
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.6 years
STANDARD_DEVIATION 5.2 • n=33 Participants
|
73.4 years
STANDARD_DEVIATION 5 • n=30 Participants
|
73.0 years
STANDARD_DEVIATION 5 • n=63 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=33 Participants
|
22 Participants
n=30 Participants
|
47 Participants
n=63 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=33 Participants
|
8 Participants
n=30 Participants
|
16 Participants
n=63 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 12 weeksThe 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.
Outcome measures
| Measure |
Backwards Walking (BW) Programme
n=22 Participants
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.
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
n=20 Participants
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.
Usual Care: A 12 week physiotherapy exercise programme EXCLUDING backwards walking
|
|---|---|---|
|
Berg Balance Scale
|
53 Score on a scale
Standard Deviation 3.5
|
52.4 Score on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 12 weeksThe 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.
Outcome measures
| Measure |
Backwards Walking (BW) Programme
n=22 Participants
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.
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
n=20 Participants
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.
Usual Care: A 12 week physiotherapy exercise programme EXCLUDING backwards walking
|
|---|---|---|
|
Four Square Step Test
|
12.8 second (s)
Standard Deviation 6.4
|
12.3 second (s)
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: 12 weeksThe 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)
Outcome measures
| Measure |
Backwards Walking (BW) Programme
n=22 Participants
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.
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
n=20 Participants
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.
Usual Care: A 12 week physiotherapy exercise programme EXCLUDING backwards walking
|
|---|---|---|
|
The Two Minute Walk Test (2MWT)
|
123.2 metres (m)
Standard Deviation 24
|
130.8 metres (m)
Standard Deviation 39.3
|
SECONDARY outcome
Timeframe: 12 weeksThe 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.
Outcome measures
| Measure |
Backwards Walking (BW) Programme
n=22 Participants
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.
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
n=20 Participants
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.
Usual Care: A 12 week physiotherapy exercise programme EXCLUDING backwards walking
|
|---|---|---|
|
30 Second Sit to Stand Test
|
11.9 score on a scale
Standard Deviation 3.4
|
11.3 score on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 12 weeksActivities-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.
Outcome measures
| Measure |
Backwards Walking (BW) Programme
n=22 Participants
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.
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
n=20 Participants
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.
Usual Care: A 12 week physiotherapy exercise programme EXCLUDING backwards walking
|
|---|---|---|
|
Activities-Specific Balance Confidence Scale
|
88.7 units on a scale
Standard Deviation 13.5
|
87.2 units on a scale
Standard Deviation 15.6
|
Adverse Events
Backwards Walking (BW) Programme
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Backwards Walking (BW) Programme
n=22 participants at risk
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.
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
n=20 participants at risk
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.
Usual Care: A 12 week physiotherapy exercise programme EXCLUDING backwards walking
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Joint dislocation
|
4.5%
1/22 • Number of events 1 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
Additional Information
Mrs Martha Batting
Oxford University Hospitals NHS Foundation Trust
Phone: 01865
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place