Digital Biofeedback System Versus Conventional Home-based Rehabilitation After Total Hip Replacement
NCT ID: NCT03045549
Last Updated: 2019-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2016-12-19
2018-07-20
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental group
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.
Digital biofeedback system
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
Conventional rehabilitation group
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.
Conventional home-based rehabilitation
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
Interventions
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Digital biofeedback system
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
Conventional home-based rehabilitation
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hospital da Prelada
OTHER
Sword Health, SA
INDUSTRY
Responsible Party
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Principal Investigators
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Fernando D Correia, MD
Role: PRINCIPAL_INVESTIGATOR
Sword Health, SA
Locations
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Hospital da Prelada - Dr. Domingos Braga da Cruz
Porto, , Portugal
Countries
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References
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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.
Other Identifiers
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SH-THR-01
Identifier Type: -
Identifier Source: org_study_id
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