Digital Biofeedback System Versus Conventional Home-based Rehabilitation After Total Hip Replacement

Not Applicable

Completed

• Conditions: Hip Arthrosis; Hip Osteoarthritis
• Interventions: Device: Digital biofeedback system; Other: Conventional home-based rehabilitation

• Registration Number: NCT03045549
• Lead Sponsor: Sword Health, SA

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-19
• Study First Submitted: 2017-02-03
• Study First Submitted QC: 2017-02-06
• Study First Posted: 2017-02-07
• Primary Completion: 2018-07-20
• Study Completion: 2018-07-20
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-03
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Patients over 18 years old
• Clinical and imaging evidence of hip osteoarthritis
• Indication for total hip replacement according to the patient´s orthopedic surgeon
• Ability to walk unaided, with unilateral or bilateral support
• Availability of a carer to assist the patient after surgery

Exclusion Criteria

• Patients admitted for revision of total hip replacement
• Contralateral hip or knee osteoarthritis severely limiting patient mobility and ability to comply with a rehabilitation program
• Aphasia, dementia or psychiatric comorbidity interfering with the communication or compliance to the rehabilitation process
• Respiratory, cardiac, metabolic or other condition incompatible with at least 30 minutes of light to moderate physical activity
• Major medical complications occurring after surgery that prevent the discharge of the patient within 7 days after the surgery
• Other medical and/or surgical complications that prevent the patient from complying with a rehabilitation program
• Blind and/or illiterate patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Digital biofeedback system	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.
Conventional rehabilitation group	Conventional home-based rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Change in the Timed Up and Go Test score	Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Change in Hip injury and Osteoarthritis Outcome Score (KOOS)	Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery	The HOOS is a standardized and validated patient outcome score that assesses functional limitation in patients with hip problems.
Change in the Range of Motion (degrees)	Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery	Change in the hip range of motion (lying flexion/adbuction; standing flexion/abduction/hyperextension) measured in degrees

Trial Locations

Locations (1)

Hospital da Prelada - Dr. Domingos Braga da Cruz; 🇵🇹 Porto, Portugal