About this trial
This study will investigate the immediate and short-term effects of capacitive-resistive radiofrequency therapy (TECAR) applied to the lower limbs in people with Parkinson's disease. The main aim is to determine which of four different TECAR application protocols produces the greatest improvement in muscle stiffness and walking function.
Twenty participants with Parkinson's disease will receive four different TECAR protocols in four separate sessions. The protocols will include capacitive treatment, resistive treatment, and two combinations of capacitive and resistive treatment. Each participant will receive all four protocols, and the order in which they are applied will be randomized. Sessions will be separated by a 7-day washout period.
Muscle stiffness will be measured using the MyotonPRO device. Walking and functional mobility will also be assessed using the Timed Up and Go test and the 10-Metre Walk Test. Joint range of motion and lower-limb musculoskeletal pain will also be evaluated. Measurements will be performed immediately before treatment, immediately after treatment, and 48 hours after each session.
The study will also record any discomfort or adverse events associated with TECAR therapy to evaluate the safety and tolerability of the different treatment protocols.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 55 and 90 years. Clinical diagnosis of idiopathic Parkinson's disease confirmed by a Neurology specialist.
Disqualifiers
Advanced Parkinson's disease, defined as Hoehn and Yahr stage >III, with severe postural instability.
Trial design
Crossover
Treatments tested in this trial
Capacitive Radiofrequency Therapy
Other interventionCapacitive-resistive radiofrequency therapy (TECAR) will be applied in capacitive mode to the lower limbs for 15 minutes per leg. Treatment will target the posterior lower leg, quadriceps, and hamstring muscle regions. Intensity will be individually adjusted to a medium-high level producing a clear but comfortable thermal effect, approximately 3-4 out of 5 on the device intensity scale.
Resistive Radiofrequency Therapy
Other interventionCapacitive-resistive radiofrequency therapy (TECAR) will be applied in resistive mode to the lower limbs for 15 minutes per leg. Treatment will target the posterior lower leg, quadriceps, and hamstring muscle regions. Intensity will be individually adjusted to a medium-high level producing a clear but comfortable thermal effect, approximately 3-4 out of 5 on the device intensity scale.
Capacitive-Resistive Radiofrequency Therapy
Other interventionCapacitive-resistive radiofrequency therapy (TECAR) will be applied to the lower limbs using a mixed protocol consisting of 10 minutes of capacitive treatment followed by 5 minutes of resistive treatment per leg. Treatment will target the posterior lower leg, quadriceps, and hamstring muscle regions. Intensity will be individually adjusted to a medium-high level producing a clear but comfortable thermal effect, approximately 3-4 out of 5 on the device intensity scale.
Resistive-Capacitive Radiofrequency Therapy
Other interventionCapacitive-resistive radiofrequency therapy (TECAR) will be applied to the lower limbs using a mixed protocol consisting of 10 minutes of resistive treatment followed by 5 minutes of capacitive treatment per leg. Treatment will target the posterior lower leg, quadriceps, and hamstring muscle regions. Intensity will be individually adjusted to a medium-high level producing a clear but comfortable thermal effect, approximately 3-4 out of 5 on the device intensity scale.
Treatment groups
Trial outcomes
Primary outcomes
Change in Lower-Limb Muscle Stiffness
Lower-limb muscle stiffness will be assessed using the MyotonPRO device and expressed in N/m. Three consecutive measurements will be performed at standardized anatomical sites on the medial gastrocnemius, tibialis anterior, rectus femoris, and biceps femoris muscles, and the mean value will be used for analysis.
Secondary outcomes
Change in Functional Mobility Assessed With the Timed Up and Go Test
Functional mobility will be assessed using the Timed Up and Go (TUG) test. The time required to stand up from a chair, walk 3 meters, turn around, walk back, and sit down will be recorded in seconds. Three attempts will be performed, and the best result will be used for analysis.
Change in Gait Speed Assessed With the 10-Metre Walk Test
Gait speed will be assessed using the 10-Metre Walk Test (10MWT) at a comfortable walking speed. Walking speed will be expressed in meters per second (m/s). Three attempts will be performed, and the best result will be used for analysis.
Change in Lower-Limb Joint Range of Motion
Range of motion of the ankle, knee, and hip will be assessed using a universal goniometer and expressed in degrees. Two measurements will be performed for each assessment, and the mean value will be used for analysis.
Change in Lower-Limb Musculoskeletal Pain
Lower-limb musculoskeletal pain will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain will be evaluated in relation to lower-limb movement and functional assessment.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.