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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03045549
• Date of registration: 03/02/2017
• Prospective Registration: No
• Primary sponsor: Sword Health, SA
• Public title: Digital Biofeedback System Versus Conventional Home-based Rehabilitation After Total Hip Replacement
• Scientific title: Home-based Rehabilitation With A Digital Biofeedback System Versus Conventional Rehabilitation After Total Hip Replacement: a Pilot Study
• Date of first enrolment: December 19, 2016
• Target sample size: 66
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03045549
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Portugal

Contacts

• Name: Fernando D Correia, MD
• Affiliation: Sword Health, SA

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hip Osteoarthritis

Hip Arthrosis

Intervention(s)

Device: Digital biofeedback system

Other: Conventional home-based rehabilitation

Primary Outcome(s)

Change in the Timed Up and Go Test score [Time Frame: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery]

Secondary Outcome(s)

Change in the Range of Motion (degrees) [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) [Time Frame: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery]

Secondary ID(s)

SH-THR-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hospital da Prelada