Clinical trial NCT06206018: Patient-Reported Outcome Measures in Lower Extremity Rehabilitation Program PROM_R: Impact on Health Care
Official title: Patient-Reported Outcome Measures in Lower Extremity Rehabilitation Program PROM_R: Impact on Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Extremity Problem
Rehabilitation
Knee Injuries
Keywords: Quality of Life
Patient-Reported Outcome Measures
Lead sponsor: University of Évora
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Different musculoskeletal conditions affect people all over the world and were considered by the WHO to be the leading cause of disability in 4 out of 6 regions in 2017, with an increase in the associated burden and impact on society expected in the coming years.

The knee is a complex joint, vulnerable to various types of injury. The most common are ligament, meniscus and cartilage injuries of different etiologies.

After surgery, as a result of the reflex inhibition of motor neurons and immobilization, there is rapid atrophy and weakness in the different associated muscles, affecting proprioception, muscle strength and extension, clearly compromising health-related quality of life.

Through partnership and collaboration between health institutions and academia, the rehabilitation program will take place on an outpatient basis in a supervised manner, allowing its effectiveness to be assessed using Patient-Reported Outcome Measures. These instruments are a rapidly developing topic and it is essential to understand whether the Patient-Reported Outcome Measures used are sufficient to measure the results perceived by patients with lower limb pathology who take part in rehabilitation programs.

The different Patient-Reported Outcome Measures will be applied before and after the program.

Detailed description: The study design is a clinical trial with longitudinal assessment, with a convenience sample. Participants who meet the inclusion criteria are invited to take part and sign an informed consent form. All participants' data is encrypted and stored with password protection, and will be deleted once the results of the study have been published.

The experimental group followed the program for 4 weeks with a treatment frequency of 5 sessions per week, performed and supervised by the same specialist physiotherapist at every session.

For the statistical analysis of the data in this study, we used the Statistical Package for Social Sciences (SPSS®) 29 software.

Eligibility criteria: Inclusion Criteria:

* Patients with knee and ankle pathology, undergoing surgery;
* That they are going to start a rehabilitation program in two Rehabilitation Clinics in coastal and inland regions of Portugal;
* Aged between 18 and 80;
* Have signed an informed consent form.

Exclusion Criteria:

* Unconsolidated fractures;
* Previous surgeries in the ipsilateral knee;
* Partial or total amputation in upper or lower limbs;
* Permanent or temporary dysfunctions of the central or peripheral nerve system.

Primary outcomes:
measure: Health-related quality of life
timeFrame: Before the intervention, after 4-6 weeks and 6 months.
measure: Hospital Anxiety and Depression Scale
timeFrame: Before the intervention, after 4-6 weeks and 6 months.
measure: Behavioural Regulations in Exercise Questionnaire
timeFrame: Before the intervention, after 4-6 weeks and 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: National School of Public Health
Study officials:
References:
citation: Logerstedt DS, Scalzitti DA, Bennell KL, Hinman RS, Silvers-Granelli H, Ebert J, Hambly K, Carey JL, Snyder-Mackler L, Axe MJ, McDonough CM. Knee Pain and Mobility Impairments: Meniscal and Articular Cartilage Lesions Revision 2018. J Orthop Sports Phys Ther. 2018 Feb;48(2):A1-A50. doi: 10.2519/jospt.2018.0301.
citation: Mundermann A, Dyrby CO, Andriacchi TP. Secondary gait changes in patients with medial compartment knee osteoarthritis: increased load at the ankle, knee, and hip during walking. Arthritis Rheum. 2005 Sep;52(9):2835-44. doi: 10.1002/art.21262.
citation: Suchomel TJ, Nimphius S, Bellon CR, Stone MH. The Importance of Muscular Strength: Training Considerations. Sports Med. 2018 Apr;48(4):765-785. doi: 10.1007/s40279-018-0862-z.
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