An interventional study of Digital biofeedback system and Conventional home-based rehabilitation in Hip Osteoarthritis and Hip Arthrosis, sponsored by Sword Health, SA. Completed at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-05.
Sponsored by Sword Health, SA · Not applicable, Interventional, and Treatment
The study was designed to compare the clinical outcomes of a home-based rehabilitation program using a novel digital biofeedback system against conventional home-based rehabilitation after total hip replacement This system allows the patients to perform independent rehabilitation sessions at home, under remote monitoring from the clinical team. The investigators hypothesise that the clinical outcomes of a home-based rehabilitation program will be at least similar to the outcomes of a traditional home-based rehabilitation with face-to-face sessions. This is a single-center, prospective, parallel-group pilot study with active comparator. Patients will be enrolled pre-operatively and then divided into 2 groups: experimental group and conventional rehabilitation group. Both groups will perform an 8-week rehabilitation program starting between day 7 and 10 after surgery.
The experimental group will perform daily exercise sessions at home using the system, under remote monitoring from a physical therapist. The conventional rehabilitation group will perform 3 home-based rehabilitation sessions per week, each with 1h duration, given by a physical therapist.
Outcomes will be measured at weeks 4 and 8 and then at 3 and 6 months. The primary outcome is the change in patient performance measured by the Timed-up-and-Go (TUG) test between in comparison with the pre-operative score. Secondary outcomes will be measured in terms of: a) Hip Osteoarthritis Outcome Score (HOOS); b) range of motion of the hip joint (lying flexion/abduction; standing flexion/adbuction/hyperextension)
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 66 is close to the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Sword Health, SA is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Home-based rehabilitation sessions performed with the digital biofeedback system. Patients will be instructed to perform exercise sessions at least 5 days a week, but compliance to this schedule is not mandatory.
Device: Digital biofeedback system
Home-based rehabilitation sessions provided by a Physical Therapist, 3 times a week, each with 1h duration. Patients will be instructed to perform 2 additional unsupervised sessions per week, but compliance to these sessions is not mandatory.
Other: Conventional home-based rehabilitation
The system will be used independently by the patients to perform rehabilitation sessions at home, under remote monitoring from the clinical team. A tailored rehabilitation program will be prescribed, based on the following principles: STAGE 1 (Weeks 0-6) Open kinetic chain exercises without added resistance: lying, sitting and standing (with support) Strengthening of hip flexors and abductors (mainly) Ice pack application STAGE 2 (weeks 7-8) Open kinetic chain exercises with added resistance: lying, sitting (high chair) and standing (with progression to standing without support) Strengthening of hip flexors and abductors (mainly) Ice pack application after each session
Also known as: SWORD Phoenix
Patients will perform 3 weekly rehabilitation sessions, with a duration of 1 hour, for 8 weeks, provided by a physical therapist. The rehabilitation program will respect the following principles: STAGE 1 (Weeks 0-6) Soft tissue massage Active assisted mobilization of the hip joint to increase range of motion (avoiding internal rotation and adduction) Gait training with bilateral assistive devices Isometric exercises progressing to open chain, low-impact, concentric exercises with strengthening of hip abductors and flexors Ice pack application STAGE 2 (weeks 7-8) Soft tissue massage Gait training with progressive withdrawal of assistive devices Balance exercises with progression to one-leg support Open-chain strengthening exercises against resistance with progression to closed-chain exercises Ice pack application
Change in the Timed Up and Go Test score
The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible.
Time frame: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery
Change in Hip injury and Osteoarthritis Outcome Score (KOOS)
The HOOS is a standardized and validated patient outcome score that assesses functional limitation in patients with hip problems.
Time frame: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery
Change in the Range of Motion (degrees)
Change in the hip range of motion (lying flexion/adbuction; standing flexion/abduction/hyperextension) measured in degrees
Time frame: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery
Plan to share: Yes — Study protocol and study aggregate results (including anonymised individual patient data) will be made available
Supporting information: Study protocol, Sap
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Sword Health, SA