Trial Outcomes & Findings for Improving Function After Knee Arthroplasty With Weight-Bearing Biofeedback (NCT NCT01333189)

Results Overview

Weight-bearing ratio is measured during transitions between sitting and standing and is indicated by symmetry in vertical ground reaction force (vGRF) between lower limbs. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

6 weeks post-operative

Results posted on

2019-04-23

Participant Flow

Participant milestones

Participant milestones
Measure	RELOAD: Weight-bearing Biofeedback Exercise RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched. Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention. Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games.	CONTROL: Standard of Care Exercise CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation. Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of \[3\] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups.
Overall Study STARTED	13	13
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	RELOAD: Weight-bearing Biofeedback Exercise RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched. Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention. Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games.	CONTROL: Standard of Care Exercise CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation. Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of \[3\] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups.
Overall Study Time constraints	1	0
Overall Study Adverse Event	1	0
Overall Study Transportation difficulties	0	1
Overall Study Moved from region	0	1

Baseline Characteristics

Improving Function After Knee Arthroplasty With Weight-Bearing Biofeedback

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RELOAD: Weight-bearing Biofeedback Exercise n=13 Participants RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched. Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention. Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games.	CONTROL: Standard of Care Exercise n=13 Participants CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation. Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of \[3\] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups.	Total n=26 Participants Total of all reporting groups
Age, Continuous	68.2 years STANDARD_DEVIATION 8.6 • n=93 Participants	66.6 years STANDARD_DEVIATION 8.1 • n=4 Participants	67.4 years STANDARD_DEVIATION 8.2 • n=27 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	7 Participants n=4 Participants	13 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	6 Participants n=4 Participants	13 Participants n=27 Participants

PRIMARY outcome

Timeframe: 6 weeks post-operative

Population: At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.

Weight-bearing ratio is measured during transitions between sitting and standing and is indicated by symmetry in vertical ground reaction force (vGRF) between lower limbs. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).

Outcome measures

Outcome measures
Measure	RELOAD: Weight-bearing Biofeedback Exercise n=12 Participants RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched. Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention. Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games.	CONTROL: Standard of Care Exercise n=12 Participants CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation. Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of \[3\] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups.
Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST)	0.77 ratio Standard Deviation 0.1	0.8 ratio Standard Deviation 0.11

SECONDARY outcome

Timeframe: 6 weeks post-operative

Population: At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.

Weight-bearing ratio is measured during walking as the ratio between lower limbs in peak vertical ground reaction force (vGRF) during the loading response phase of the stance period of gait. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).

Outcome measures

Outcome measures
Measure	RELOAD: Weight-bearing Biofeedback Exercise n=12 Participants RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched. Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention. Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games.	CONTROL: Standard of Care Exercise n=12 Participants CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation. Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of \[3\] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups.
Weight-bearing Ratio During Walking	0.94 ratio Standard Deviation 0.08	0.92 ratio Standard Deviation 0.09

SECONDARY outcome

Timeframe: 6 weeks post-operative

Population: At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.

The Five Times Sit-to-Stand Test is quantified as the total time required for an individual to rise from and return to a chair five times in a row.

Outcome measures

Outcome measures
Measure	RELOAD: Weight-bearing Biofeedback Exercise n=12 Participants RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched. Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention. Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games.	CONTROL: Standard of Care Exercise n=12 Participants CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation. Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of \[3\] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups.
Five Times Sit-to-Stand Test (FTSST)	11.5 seconds Standard Deviation 1.6	12.7 seconds Standard Deviation 3.3

SECONDARY outcome

Timeframe: 6 weeks post-operative

Population: At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.

Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.

Outcome measures

Outcome measures
Measure	RELOAD: Weight-bearing Biofeedback Exercise n=12 Participants RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched. Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention. Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games.	CONTROL: Standard of Care Exercise n=12 Participants CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation. Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of \[3\] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups.
Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test Hip Moment	0.73 Newton-meters per kilogram (Nm/kg) Standard Deviation 0.28	0.80 Newton-meters per kilogram (Nm/kg) Standard Deviation 0.26
Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test Knee Moment	0.77 Newton-meters per kilogram (Nm/kg) Standard Deviation 0.21	0.72 Newton-meters per kilogram (Nm/kg) Standard Deviation 0.18
Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test Ankle Moment	0.29 Newton-meters per kilogram (Nm/kg) Standard Deviation 0.14	0.31 Newton-meters per kilogram (Nm/kg) Standard Deviation 0.17

SECONDARY outcome

Timeframe: 6 weeks post-operative

Population: At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.

Self-selected walking speed was recorded for three passes across the middle 6 meter section of a walkway. The average of the 3 passes is reported.

Outcome measures

Outcome measures
Measure	RELOAD: Weight-bearing Biofeedback Exercise n=12 Participants RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched. Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention. Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games.	CONTROL: Standard of Care Exercise n=12 Participants CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation. Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of \[3\] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups.
Walking Speed	1.20 meters/second Standard Deviation 0.23	1.16 meters/second Standard Deviation 0.2

SECONDARY outcome

Timeframe: 6 weeks post-operative

Population: At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.

Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.