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Telerehabilitation Gait Modification

Foot Progression Angle Modification: an Exploratory Six-week Telerehabilitation Intervention in People With Knee Osteoarthritis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04683913
Acronym
TELEMOD
Enrollment
20
Registered
2020-12-24
Start date
2021-01-01
Completion date
2022-05-20
Last updated
2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

Gait Modification, Wearable Sensors, Real-world Monitoring, Telerehabilitation

Brief summary

Excessive knee joint loads during walking can contribute to knee osteoarthritis progression. Changing the rotation of the foot (in-toeing or out-toeing) while walking can lower knee joint loads and improve pain and function. Telerehabilitation (using video or telephone communication to delivery rehabilitation) has shown promise in delivering exercise therapy for knee osteoarthritis, but it is unknown if walking modifications can be delivered using this method. This study consists of a six-week walking modification program in people with knee osteoarthritis. Performance of the modification will be measured using motion capture and wearable sensors during practice and daily life.

Detailed description

Loads on the knee joint during walking are related to worsening of knee osteoarthritis. Changing walking motions to lower these knee joint loads is an emerging management strategy for knee osteoarthritis. Multiple studies have targeted a change in the position of the foot relative to the direction of walking (toe-in or toe-out walking) and have shown this walking modification to lower knee joint loads and improve symptoms (e.g. pain) related to knee osteoarthritis within the context of a walking program. Building off the many studies that have found telerehabilitation to be an effective method of providing exercise and pain-coping physical therapy, the investigators will use this method to provide walking modification treatment. Telerehabilitation (using video or teleconferencing to conduct the physical therapy appointment) provides a convenient and cost-effective method to work with patients and coordinate their treatment plan. To monitor progress with learning the walking modification, the investigators will use a custom sensor shoe that the participants will wear during daily walking activities over the six-week intervention. Overall, this study will investigate the feasibility and effectiveness of a walking modification program delivered using video- or teleconference.

Interventions

BEHAVIORALFoot rotation modification

The instruction of gait modification provided via teleconferencing sessions (5 over 6 weeks) focusing on increasing toe-in or toe-out angles by as much as is comfortable.

OTHERWaiting Period - Delayed Group

Participants allocated to the Delayed Group will wait 6 weeks after their initial baseline, then complete a second baseline to provide a control condition. After the second baseline they will enter the intervention.

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Two-arm delayed control design

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 50 years of age or older * Exhibit signs of tibiofemoral osteoarthritis based on a score of ≥2 on the Kellgren and Lawrence grading scale predominantly in the medial compartment. * Self-reported knee pain ≥ 3 / 10 on a numerical rating scale of pain (NRS; 0 = no pain and 10 = worst pain imaginable) during most days of the previous month * Comfortable walking intermittently for 30 minutes * Fit into the available sizes of sensor shoes (between US women's 5 to men's 13) * Exhibits ≥2% reduction in knee adduction moment impulse at 10 degrees of change in toe-in or toe-out during the screening appointment.

Exclusion criteria

* Any knee surgery or intraarticular injections within the past 6 months * A history of joint replacement surgery or high tibial osteotomy * Current or recent (within 6 weeks) corticosteroid injections * Use of a gait aid * Currently on a wait list for joint replacement surgery or high tibial osteotomy * Any inflammatory arthritic condition * Any other conditions that may affect normal gait or participation in an aerobic exercise program * Cannot attend all required appointments

Design outcomes

Primary

MeasureTime frameDescription
Satisfaction With the Treatment ProgramWeek 6Satisfaction with the gait modification program on a 7-point Likert scale where -3 = extremely unsatisfied and +3 = extremely satisfied. Scores of +2 or +3 will be considered satisfied and acceptable.
Intervention AdherenceWeek 6Adherence will be measured by the ratio of telerehabilitation sessions the participant attends relative to the total sessions (5 total).
Compliance With Gait ModificationWeek 6Compliance will be estimated by self-reported confidence in performing the gait modification (where 0 = no confidence and 10 = complete confidence) at follow up. Acceptable confidence ratings by week 6 are greater than or equal to 7/10.
Difficulty in Performing the ModificationWeek 6Difficulty of performing the modification at week 6. Difficulty measured on an NRS scale (0 = no difficulty and 10 = most difficulty possible). Acceptable difficulty by week 6 is less than or equal to 4/10.
Lab-measured Performance of Gait ModificationBaseline, Week 6Change in foot rotation angle between baseline and week 6 (follow-up) appointments measured using marker-based motion capture. Foot rotation is defined as the angle between the long axis of the foot and the walking direction. Measures of central tendency and variability will be extracted.
Real-world Performance of Gait ModificationBaseline, Week 1&2, Week 3&4, Week 5&6, Follow up (Week 6/12), Retention (Week 10/16)Change in absolute median foot rotation from baseline to each real-world walking bout (represented as a single data file on the sensor module), follow-up, and retention measured via the sensor shoe. Foot rotation is defined as the angle between the long axis of the foot and the walking direction. Measures of central tendency and variability will be extracted, in addition to the proportion of steps with a greater than or equal to 7 degree change.

Secondary

MeasureTime frameDescription
Knee Joint MomentsBaseline, Week 6Peaks and impulse of the knee adduction moment and knee flexion moment measured via in-laboratory gait analysis (force platforms and marker-based motion capture) at baseline, and follow up.
Knee Joint Moment ImpulseBaseline, Week 6Impulse of the knee adduction and flexion moments.
Knee-osteoarthritis Related SymptomsBaseline, Week 6Change in pain (9 items), stiffness (7 items), physical function (17 items), and quality of life (4 items) will be measured by the Knee Injury and Osteoarthritis Outcome Score at baseline, follow up and retention. Each item is rated on a 5 points Likert scale where 0 = No problems and 4 = Extreme Problems. Higher scores indicate better function. The scores are normalized to 0-100%.

Countries

Canada

Participant flow

Recruitment details

Two recruitment drives were completed using online social media outlets between January 2021 and May 2021. The drives garnered 134 respondents (72 and 62, respectively) who were preliminarily screened for study inclusion/exclusion. Sixty individuals underwent radiographic screening and 28 underwent biomechanical screening for response to gait modification. A total of 20 participants completed baseline assessments and were randomized.

Pre-assignment details

Participants completed a biomechanical screen involving normal and modified walking in a motion capture space. The data were used to calculate the knee adduction moment impulse (main biomechanical outcome) and foot progression angle (modification target). Those who did not reduce their knee adduction moment impulse \>5% were not included in the study.

Participants by arm

ArmCount
Immediate Intervention: Telerehabilitation
Immediate entry into the gait modification intervention delivered using teleconferencing methods Foot rotation modification: The instruction of gait modification provided via teleconferencing sessions (5 over 6 weeks) focusing on increasing toe-in or toe-out angles by as much as is comfortable.
10
Delayed Intervention: Telerehabilitation
Delayed (6 weeks) entry into the gait modification intervention delivered using teleconferencing methods Foot rotation modification: The instruction of gait modification provided via teleconferencing sessions (5 over 6 weeks) focusing on increasing toe-in or toe-out angles by as much as is comfortable. Waiting Period - Delayed Group: Participants allocated to the Delayed Group will wait 6 weeks after their initial baseline, then complete a second baseline to provide a control condition. After the second baseline they will enter the intervention.
10
Total20

Baseline characteristics

CharacteristicTotalDelayed Intervention: TelerehabilitationImmediate Intervention: Telerehabilitation
Age, Continuous67.4 years
STANDARD_DEVIATION 5.5
67.9 years
STANDARD_DEVIATION 3.2
66.8 years
STANDARD_DEVIATION 7.2
Body Mass75.4 kg
STANDARD_DEVIATION 14.9
75.2 kg
STANDARD_DEVIATION 11.7
75.7 kg
STANDARD_DEVIATION 18.1
Body Mass Index26.5 kg/m^2
STANDARD_DEVIATION 4.2
26.2 kg/m^2
STANDARD_DEVIATION 3.8
26.8 kg/m^2
STANDARD_DEVIATION 4.7
Foot Progression Angle Direction Prescription
Toe-in
11 Participants5 Participants6 Participants
Foot Progression Angle Direction Prescription
Toe-out
9 Participants5 Participants4 Participants
Height168.3 cm
STANDARD_DEVIATION 9.1
169.3 cm
STANDARD_DEVIATION 9.1
167.3 cm
STANDARD_DEVIATION 9.6
Kellgren and Lawrence Grade
Kellgren and Lawrence 2
7 Participants3 Participants4 Participants
Kellgren and Lawrence Grade
Kellgren and Lawrence 3
7 Participants4 Participants3 Participants
Kellgren and Lawrence Grade
Kellgren and Lawrence 4
6 Participants3 Participants3 Participants
Knee Symptom Laterality
Bilateral
14 Participants5 Participants9 Participants
Knee Symptom Laterality
Unilateral
6 Participants5 Participants1 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Canada
10 participants10 participants10 participants
Sex: Female, Male
Female
17 Participants8 Participants9 Participants
Sex: Female, Male
Male
3 Participants2 Participants1 Participants
Symptom Duration97.2 months
STANDARD_DEVIATION 75.2
80.2 months
STANDARD_DEVIATION 78.3
114.3 months
STANDARD_DEVIATION 72

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 10
other
Total, other adverse events
7 / 108 / 10
serious
Total, serious adverse events
0 / 100 / 10

Outcome results

Primary

Compliance With Gait Modification

Compliance will be estimated by self-reported confidence in performing the gait modification (where 0 = no confidence and 10 = complete confidence) at follow up. Acceptable confidence ratings by week 6 are greater than or equal to 7/10.

Time frame: Week 6

ArmMeasureValue (MEAN)Dispersion
Immediate Intervention: TelerehabilitationCompliance With Gait Modification8.7 score on a scaleStandard Deviation 1.3
Delayed Intervention: TelerehabilitationCompliance With Gait Modification8.4 score on a scaleStandard Deviation 1.3
Primary

Difficulty in Performing the Modification

Difficulty of performing the modification at week 6. Difficulty measured on an NRS scale (0 = no difficulty and 10 = most difficulty possible). Acceptable difficulty by week 6 is less than or equal to 4/10.

Time frame: Week 6

ArmMeasureValue (MEAN)Dispersion
Immediate Intervention: TelerehabilitationDifficulty in Performing the Modification1.9 score on a scaleStandard Deviation 1.7
Delayed Intervention: TelerehabilitationDifficulty in Performing the Modification2.0 score on a scaleStandard Deviation 1.6
Primary

Intervention Adherence

Adherence will be measured by the ratio of telerehabilitation sessions the participant attends relative to the total sessions (5 total).

Time frame: Week 6

ArmMeasureValue (MEAN)
Immediate Intervention: TelerehabilitationIntervention Adherence100 percent of sessions attended
Delayed Intervention: TelerehabilitationIntervention Adherence100 percent of sessions attended
Primary

Lab-measured Performance of Gait Modification

Change in foot rotation angle between baseline and week 6 (follow-up) appointments measured using marker-based motion capture. Foot rotation is defined as the angle between the long axis of the foot and the walking direction. Measures of central tendency and variability will be extracted.

Time frame: Baseline, Week 6

ArmMeasureGroupValue (MEAN)
Immediate Intervention: TelerehabilitationLab-measured Performance of Gait ModificationBaseline6.32 degrees
Immediate Intervention: TelerehabilitationLab-measured Performance of Gait ModificationWeek 611.22 degrees
Delayed Intervention: TelerehabilitationLab-measured Performance of Gait ModificationBaseline5.71 degrees
Delayed Intervention: TelerehabilitationLab-measured Performance of Gait ModificationWeek 65.64 degrees
p-value: <0.001ANCOVA
Primary

Real-world Performance of Gait Modification

Change in absolute median foot rotation from baseline to each real-world walking bout (represented as a single data file on the sensor module), follow-up, and retention measured via the sensor shoe. Foot rotation is defined as the angle between the long axis of the foot and the walking direction. Measures of central tendency and variability will be extracted, in addition to the proportion of steps with a greater than or equal to 7 degree change.

Time frame: Baseline, Week 1&2, Week 3&4, Week 5&6, Follow up (Week 6/12), Retention (Week 10/16)

ArmMeasureGroupValue (MEAN)Dispersion
Immediate Intervention: TelerehabilitationReal-world Performance of Gait ModificationFollow up11.9 degreesStandard Deviation 6.6
Immediate Intervention: TelerehabilitationReal-world Performance of Gait ModificationWeek 1&28.0 degreesStandard Deviation 7.1
Immediate Intervention: TelerehabilitationReal-world Performance of Gait ModificationWeek 3&410.8 degreesStandard Deviation 6.7
Immediate Intervention: TelerehabilitationReal-world Performance of Gait ModificationWeek 5&612.0 degreesStandard Deviation 6.6
Immediate Intervention: TelerehabilitationReal-world Performance of Gait ModificationRetention5.9 degreesStandard Deviation 3.2
Delayed Intervention: TelerehabilitationReal-world Performance of Gait ModificationRetention9.73 degreesStandard Deviation 4.5
Delayed Intervention: TelerehabilitationReal-world Performance of Gait ModificationWeek 5&67.7 degreesStandard Deviation 4.4
Delayed Intervention: TelerehabilitationReal-world Performance of Gait ModificationWeek 1&25.3 degreesStandard Deviation 3.9
Delayed Intervention: TelerehabilitationReal-world Performance of Gait ModificationFollow up10.9 degreesStandard Deviation 4.6
Delayed Intervention: TelerehabilitationReal-world Performance of Gait ModificationWeek 3&49.26 degreesStandard Deviation 3.4
Comparison: The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retentionp-value: 0.027t-test, 2 sided
Comparison: The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retentionp-value: 1t-test, 2 sided
Comparison: The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retentionp-value: 0.078t-test, 2 sided
Comparison: The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retentionp-value: 0.015t-test, 2 sided
Comparison: The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retentionp-value: 0.567t-test, 2 sided
Comparison: The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retentionp-value: 0.001t-test, 2 sided
Comparison: The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retentionp-value: 1t-test, 2 sided
Comparison: The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retentionp-value: 0.205t-test, 2 sided
Comparison: The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retentionp-value: 0.162t-test, 2 sided
Comparison: The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retentionp-value: 0.421t-test, 2 sided
Primary

Satisfaction With the Treatment Program

Satisfaction with the gait modification program on a 7-point Likert scale where -3 = extremely unsatisfied and +3 = extremely satisfied. Scores of +2 or +3 will be considered satisfied and acceptable.

Time frame: Week 6

ArmMeasureValue (MEDIAN)
Immediate Intervention: TelerehabilitationSatisfaction With the Treatment Program2.5 score on a scale
Delayed Intervention: TelerehabilitationSatisfaction With the Treatment Program2 score on a scale
Secondary

Knee Joint Moment Impulse

Impulse of the knee adduction and flexion moments.

Time frame: Baseline, Week 6

ArmMeasureGroupValue (MEAN)
Immediate Intervention: TelerehabilitationKnee Joint Moment ImpulseKAM Impulse Baseline0.16 Nm/kg*s
Immediate Intervention: TelerehabilitationKnee Joint Moment ImpulseKFM Impulse Baseline0.1 Nm/kg*s
Immediate Intervention: TelerehabilitationKnee Joint Moment ImpulseKAM Impulse Week 60.15 Nm/kg*s
Immediate Intervention: TelerehabilitationKnee Joint Moment ImpulseKFM Impulse Week 60.11 Nm/kg*s
Delayed Intervention: TelerehabilitationKnee Joint Moment ImpulseKAM Impulse Week 60.17 Nm/kg*s
Delayed Intervention: TelerehabilitationKnee Joint Moment ImpulseKAM Impulse Baseline0.18 Nm/kg*s
Delayed Intervention: TelerehabilitationKnee Joint Moment ImpulseKFM Impulse Week 60.13 Nm/kg*s
Delayed Intervention: TelerehabilitationKnee Joint Moment ImpulseKFM Impulse Baseline0.13 Nm/kg*s
Comparison: Knee adduction moment impulses were analyzed as raw Nm\*s with body mass entered as as covariate.p-value: 0.186ANCOVA
Comparison: Knee flexion moment impulses were analyzed as raw Nm\*s with body mass entered as as covariate.p-value: 0.601ANCOVA
Secondary

Knee Joint Moments

Peaks and impulse of the knee adduction moment and knee flexion moment measured via in-laboratory gait analysis (force platforms and marker-based motion capture) at baseline, and follow up.

Time frame: Baseline, Week 6

ArmMeasureGroupValue (MEAN)
Immediate Intervention: TelerehabilitationKnee Joint MomentsBaseline KAM10.56 Nm/kg
Immediate Intervention: TelerehabilitationKnee Joint MomentsWeek 6 KAM10.49 Nm/kg
Immediate Intervention: TelerehabilitationKnee Joint MomentsBaseline KAM20.30 Nm/kg
Immediate Intervention: TelerehabilitationKnee Joint MomentsWeek 6 KAM20.28 Nm/kg
Immediate Intervention: TelerehabilitationKnee Joint MomentsBaseline KFM peak0.70 Nm/kg
Immediate Intervention: TelerehabilitationKnee Joint MomentsWeek 6 KFM peak0.72 Nm/kg
Delayed Intervention: TelerehabilitationKnee Joint MomentsBaseline KFM peak0.66 Nm/kg
Delayed Intervention: TelerehabilitationKnee Joint MomentsBaseline KAM10.50 Nm/kg
Delayed Intervention: TelerehabilitationKnee Joint MomentsWeek 6 KAM20.32 Nm/kg
Delayed Intervention: TelerehabilitationKnee Joint MomentsWeek 6 KAM10.45 Nm/kg
Delayed Intervention: TelerehabilitationKnee Joint MomentsWeek 6 KFM peak0.68 Nm/kg
Delayed Intervention: TelerehabilitationKnee Joint MomentsBaseline KAM20.33 Nm/kg
Comparison: Knee adduction moment 1 (early stance) was analyzed as raw Nm with body mass entered as as covariate.p-value: 0.342ANCOVA
Comparison: Knee Adduction Moment 2 (late stance was analyzed as raw Nm with body mass entered as as covariate.p-value: 0.844ANCOVA
Comparison: Knee Flexion Moments were analyzed as raw Nm with body mass entered as as covariatep-value: 0.774ANCOVA
Secondary

Knee-osteoarthritis Related Symptoms

Change in pain (9 items), stiffness (7 items), physical function (17 items), and quality of life (4 items) will be measured by the Knee Injury and Osteoarthritis Outcome Score at baseline, follow up and retention. Each item is rated on a 5 points Likert scale where 0 = No problems and 4 = Extreme Problems. Higher scores indicate better function. The scores are normalized to 0-100%.

Time frame: Baseline, Week 6

ArmMeasureGroupValue (MEAN)
Immediate Intervention: TelerehabilitationKnee-osteoarthritis Related SymptomsBaseline Pain60.6 scores on a scale
Immediate Intervention: TelerehabilitationKnee-osteoarthritis Related SymptomsWeek 6 Pain65.0 scores on a scale
Immediate Intervention: TelerehabilitationKnee-osteoarthritis Related SymptomsBaseline Stiffness55.0 scores on a scale
Immediate Intervention: TelerehabilitationKnee-osteoarthritis Related SymptomsWeek 6 Stiffness65.0 scores on a scale
Immediate Intervention: TelerehabilitationKnee-osteoarthritis Related SymptomsBaseline Physical Function65.9 scores on a scale
Immediate Intervention: TelerehabilitationKnee-osteoarthritis Related SymptomsWeek 6 Physical Function74.3 scores on a scale
Immediate Intervention: TelerehabilitationKnee-osteoarthritis Related SymptomsBaseline Quality of Life41.0 scores on a scale
Immediate Intervention: TelerehabilitationKnee-osteoarthritis Related SymptomsWeek 6 Quality of Life47.0 scores on a scale
Delayed Intervention: TelerehabilitationKnee-osteoarthritis Related SymptomsWeek 6 Quality of Life48.5 scores on a scale
Delayed Intervention: TelerehabilitationKnee-osteoarthritis Related SymptomsBaseline Pain59.2 scores on a scale
Delayed Intervention: TelerehabilitationKnee-osteoarthritis Related SymptomsBaseline Physical Function72.9 scores on a scale
Delayed Intervention: TelerehabilitationKnee-osteoarthritis Related SymptomsWeek 6 Pain61.9 scores on a scale
Delayed Intervention: TelerehabilitationKnee-osteoarthritis Related SymptomsBaseline Quality of Life42.0 scores on a scale
Delayed Intervention: TelerehabilitationKnee-osteoarthritis Related SymptomsBaseline Stiffness60.7 scores on a scale
Delayed Intervention: TelerehabilitationKnee-osteoarthritis Related SymptomsWeek 6 Physical Function77.6 scores on a scale
Delayed Intervention: TelerehabilitationKnee-osteoarthritis Related SymptomsWeek 6 Stiffness61.4 scores on a scale
Comparison: Knee Injury and Osteoarthritis Outcome Scale - pain subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.p-value: 0.75ANCOVA
Comparison: Knee Injury and Osteoarthritis Outcome Scale - stiffness subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.p-value: 0.201ANCOVA
Comparison: Knee Injury and Osteoarthritis Outcome Scale - physical function subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.p-value: 0.997ANCOVA
Comparison: Knee Injury and Osteoarthritis Outcome Scale - quality of life subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.p-value: 0.423ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026