Patient-Reported Outcome Measures in Lower Extremity Rehabilitation Program PROM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-10

Study Completion Date

2024-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Knee Care @Home Programme Following Anterior Ligament Reconstruction

NCT05828355

Anterior Cruciate Ligament Reconstruction

RECRUITING NA

Knee Functionality Recovery Indicators in Athletes Submitted to Ligamentoplasty of the Anterior Cruciate Ligament

NCT06050005

Ligament Injury Ligament Rupture Ligament Disorders

UNKNOWN NA

Determinants of Early Functional Outcome After Reconstructive Surgery

NCT02381873

Osteoarthritis

COMPLETED

The Effect of a Treatment Protocol Focused on Neuromuscular Control Exercises on Pain and Function in a Subgroup of Individuals With Patellofemoral Pain

NCT06893289

Patellofemoral Pain

NOT_YET_RECRUITING NA

Multimodal Assessment of Knee Conditions in Rehabilitation

NCT03608189

ACL Injury

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lower Extremity Problem Rehabilitation Knee Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PROM_R Knee

Completed a rehabilitation program based on the updated Journal of Orthopaedic and Sports Physical Therapy (JOSPT) guidelines for knee injuries. These guidelines essentially refer to lower limb massage, mobilization, neuromuscular strengthening and rehabilitation, exercise literacy, neuromuscular electrical stimulation and cryotherapy.

The intervention group will complete the four-week rehabilitation program, with five sessions per week, performed and supervised by the physiotherapist.

Group Type EXPERIMENTAL

PROM_R knee rehabilitation program

Intervention Type PROCEDURE

The rehabilitation program consists of 5 weekly sessions for 4 weeks, supervised by a specialized physiotherapist at every session.

All patients follow the same order of treatment and exercises, starting with massage and mobilization, followed by the corresponding exercise program, and ending with Neuromuscular Electrical Stimulation (NMES) and cryotherapy.

Crontrol Group

The control group will follow a standard six-week rehabilitation program.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PROM_R knee rehabilitation program

The rehabilitation program consists of 5 weekly sessions for 4 weeks, supervised by a specialized physiotherapist at every session.

All patients follow the same order of treatment and exercises, starting with massage and mobilization, followed by the corresponding exercise program, and ending with Neuromuscular Electrical Stimulation (NMES) and cryotherapy.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No