Hip Osteoarthritis Clinical Trial
Official title:
Home-based Rehabilitation With A Digital Biofeedback System Versus Conventional Rehabilitation After Total Hip Replacement: a Pilot Study
Verified date | February 2019 |
Source | Sword Health, SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 66 |
Est. completion date | July 20, 2018 |
Est. primary completion date | July 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Portugal | Hospital da Prelada - Dr. Domingos Braga da Cruz | Porto |
Lead Sponsor | Collaborator |
---|---|
Sword Health, SA | Hospital da Prelada |
Portugal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery | |
Secondary | 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. | Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery | |
Secondary | Change in the Range of Motion (degrees) | Change in the hip range of motion (lying flexion/adbuction; standing flexion/abduction/hyperextension) measured in degrees | Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery |
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