Clinical trial NCT03045549: Digital Biofeedback System Versus Conventional Home-based Rehabilitation After Total Hip Replacement
Official title: Home-based Rehabilitation With A Digital Biofeedback System Versus Conventional Rehabilitation After Total Hip Replacement: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Hip Arthrosis
Lead sponsor: Sword Health, SA
Sponsor class: INDUSTRY
Collaborators: name: Hospital da Prelada
First posted: 2017-02-07
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Change in the Timed Up and Go Test score
timeFrame: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery
Secondary outcomes:
measure: Change in Hip injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery
measure: Change in the Range of Motion (degrees)
timeFrame: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Hospital da Prelada - Dr. Domingos Braga da Cruz
Study officials:
affiliation: Sword Health, SA
name: Fernando D Correia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dias Correia F, Nogueira A, Magalhaes I, Guimaraes J, Moreira M, Barradas I, Molinos M, Teixeira L, Pires J, Seabra R, Lains J, Bento V. Digital Versus Conventional Rehabilitation After Total Hip Arthroplasty: A Single-Center, Parallel-Group Pilot Study. JMIR Rehabil Assist Technol. 2019 Jun 21;6(1):e14523. doi: 10.2196/14523.