Pilot Study on Personalized Total Knee Arthroplasty (TKA) Rehabilitation Using Telemedicine and Psychoeducation
NCT ID: NCT07032805
Last Updated: 2025-12-23
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
44 participants
INTERVENTIONAL
2025-02-28
2025-10-31
Brief Summary
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The main research questions are: • Primary: Reduction of pain (VAS), physical function (WOMAC, KOOS). • Secondary: Activities of daily living (Barthel Index, mRS); psycho-behavioral assessments (CEQ, PAM13, CG-PAM, COP-NIV); attitude toward technology (TAM); use of analgesics and walking aids.
Sample size is estimated at 40 patients (20 per group), accounting for a 20% dropout rate, divided into: • Control Group: Standard outpatient rehabilitative treatment with a personalized exercise program. • Study Group: Standard outpatient rehabilitative treatment with a personalized exercise program plus telemonitoring via video calls.
Procedures: • Recruitment and signing of informed consent; • Initial assessment (demographics, baseline tests, and posturography) and initiation of post-acute rehabilitation during hospitalization at T0; • Outpatient rehabilitative interventions with/without tele-rehabilitation support (twice weekly) at discharge, with follow-up assessments at T1 (1.5 months) and T2 (3 months); • Weekly recording of analgesic consumption via a dedicated diary; • Recording the date of discontinuation of walking aids.
Detailed Description
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Inclusion criteria (in addition to those already mentioned in the brief summary):
Ability to stand on one leg.
Exclusion criteria:
Post-traumatic or inflammatory knee OA. Valgus/varus deformity (hip-knee-ankle angle \> or \< 10°). The control group and the study group, after medical, physiotherapeutic, and psychological assessment, will undergo a posturographic examination and will then receive a treatment focused on strengthening lower limb muscles, improving joint range of motion, enhancing balance, and gait training. This will be delivered in two physiotherapy sessions per day, each lasting 45 minutes, during the 22-25 days of hospitalization.
Following discharge, participants will receive outpatient treatment consisting of two 45-minute sessions per week for three months at a physiotherapy clinic. The control group will follow this program as usual, while the study group will have the same program reinforced with home supervision via telemedicine. A physiotherapist, trained on the initial posturography findings and psychological assessments, will conduct teleconsultations using Zoom (with end-to-end encryption).
Patient characteristics and outcome measures will be reported in aggregate form, as mean ± standard deviation for continuous variables and absolute frequencies (percentages) for categorical variables. Statistical analysis of outcomes will include testing the significance of differences. The two groups will be compared based on baseline characteristics and changes in outcomes.
The Wilcoxon signed-rank test will be used to evaluate intra-group differences and the effects of the physiotherapy program. The Mann-Whitney U test will be employed to assess differences between groups and evaluate the effect of tele-rehabilitation. The chi-square (χ²) test will be used to verify the homogeneity of categorical variable distributions across the two groups. Statistical significance will be set at p \< 0.05. The effect size (ES) for the Mann-Whitney U test will be calculated in the case of between-group comparisons.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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outpatient rehabilitative treatment plus tele-rehabilitation
The study group, after medical, physiotherapeutic, and psychological assessment, will undergo a posturographic exam. They will then receive a treatment focused on strengthening lower limb muscles, improving joint range of motion, enhancing balance, and developing walking ability. This will be delivered in two daily physiotherapy sessions, each lasting 45 minutes, over the 22-25 days of hospitalization. After discharge, they will continue outpatient treatment with two 45-minute sessions per week for three months at a physiotherapy clinic. Additionally, they will receive home supervision from a physiotherapist via telemedicine (video calls using Zoom with encryption), trained on the patient's initial issues identified through posturography and psychological evaluation.
personalized outpatient rehabilitation treatment after TKA
personalized outpatients rehabilitation treatment after TKA, including posturographic assessment, psychomotivational framing, and telemedicine-based rehabilitation interventions
Standard outpatient rehabilitative treatment
The control group, after medical, physiotherapeutic, and psychological assessments, will undergo a posturographic examination. They will then receive treatment focused on strengthening lower limb muscles, improving joint range of motion, enhancing balance, and gait training. This will be administered in two physiotherapy sessions per day, each lasting 45 minutes, over the 22-25 days of hospitalization. After discharge, they will continue with outpatient physiotherapy consisting of two 45-minute sessions per week for three months at an outpatient physiotherapy clinic.
standard outpatient rehabilitation treatment after TKA
standard outpatient rehabilitation treatment after TKA
Interventions
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personalized outpatient rehabilitation treatment after TKA
personalized outpatients rehabilitation treatment after TKA, including posturographic assessment, psychomotivational framing, and telemedicine-based rehabilitation interventions
standard outpatient rehabilitation treatment after TKA
standard outpatient rehabilitation treatment after TKA
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) \< 35;
* Ability to stand on one leg;
* Absence of active known neurological or oncological diseases.
Exclusion Criteria
* Valgus/varus deformity (hip-knee-ankle angle \> or \< 10°).
50 Years
75 Years
ALL
No
Sponsors
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Università degli Studi 'G. d'Annunzio' Chieti e Pescara
OTHER
Laura Belinda Rizzo
OTHER
Responsible Party
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Laura Belinda Rizzo
Principal Investigator
Principal Investigators
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Marisa Megna, Professor
Role: STUDY_DIRECTOR
University Bari "A. Moro"
Teresa Paolucci, Research
Role: STUDY_DIRECTOR
University of Chieti-Pescara "G. D'Annunzio"
Laura B Rizzo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Bari "A. Moro"
Locations
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Presidio territoriale di recupero e riabilitazione funzionale "San Giovanni di Dio" Conssi welfare
Adelfia, Bari, Italy
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Prot.2114/CEL
Identifier Type: -
Identifier Source: org_study_id