Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT07032805
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2025-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study on Personalized Total Knee Arthroplasty (TKA) Rehabilitation Using Telemedicine and Psychoeducation
Sponsor:
Laura Belinda Rizzo
Organization:
Study Overview
Official Title:
Telemedicine in Personalized Home Rehabilitation Following Total Knee Arthroplasty (TKA): a Pilot Study
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TKA
Brief Summary:
The objective of this clinical trial is to assess the effectiveness of a telemedicine approach in improving treatment adherence and functional outcomes in patients who have recently undergone total knee arthroplasty for primary osteoarthritis. The study focuses on patients aged between 50 and 75 years, with a BMI less than 35, and without known oncological or neurological diseases. Participants will receive personalized rehabilitation treatment, including posturographic assessment, psychomotivational framing, and telemedicine-based rehabilitation interventions. The aim is to provide a framework for adopting more detailed and personalized rehabilitative strategies.
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.
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:
To ensure quality and ethical standards in the design and implementation of our randomized clinical trial (RCT), we will apply the Helsinki criteria and the CONSORT checklist. All patients hospitalized for rehabilitation after total knee arthroplasty (TKA) at the San Giovanni di Dio Rehabilitation Center in Adelfia (BA) will be evaluated for eligibility to participate in a clinical study on primary symptomatic osteoarthritis (OA) of the knee between February and May 2025.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: