NCT07842926

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Sep 2026Dec 2026

First Submitted

Initial submission to the registry

September 21, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

September 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

September 21, 2026

Last Update Submit

September 21, 2026

Conditions

Keywords

Capacitive-Resistive Radiofrequency TherapyTECAR TherapyMyotonometryPhysical TherapyMuscle StiffnessRehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Immediately before, immediately after, and 48 hours after each intervention session

Secondary Outcomes (5)

  • Change in Functional Mobility Assessed With the Timed Up and Go Test

    Immediately before, immediately after, and 48 hours after each intervention session

  • Change in Gait Speed Assessed With the 10-Metre Walk Test

    Immediately before, immediately after, and 48 hours after each intervention session

  • Change in Lower-Limb Joint Range of Motion

    Immediately before, immediately after, and 48 hours after each intervention session

  • Change in Lower-Limb Musculoskeletal Pain

    Immediately before, immediately after, and 48 hours after each intervention session

  • Incidence of Treatment-Related Adverse Events

    During each intervention session and up to 48 hours after each intervention

Study Arms (4)

Capacitive TECAR Therapy

EXPERIMENTAL

Participants will receive capacitive-resistive radiofrequency therapy (TECAR) 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. Treatment 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.

Other: Capacitive Radiofrequency Therapy

Resistive TECAR Therapy

EXPERIMENTAL

Participants will receive capacitive-resistive radiofrequency therapy (TECAR) 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. Treatment 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.

Other: Resistive Radiofrequency Therapy

Capacitive-Resistive TECAR Therapy

EXPERIMENTAL

Participants will receive capacitive-resistive radiofrequency therapy (TECAR) 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. Treatment 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.

Other: Capacitive-Resistive Radiofrequency Therapy

Resistive-Capacitive TECAR Therapy

EXPERIMENTAL

Participants will receive capacitive-resistive radiofrequency therapy (TECAR) 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. Treatment 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

Other: Resistive-Capacitive Radiofrequency Therapy

Interventions

Capacitive-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.

Resistive TECAR Therapy

Capacitive-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.

Capacitive-Resistive TECAR Therapy

Capacitive-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.

Resistive-Capacitive TECAR Therapy

Capacitive-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.

Capacitive TECAR Therapy

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 55 and 90 years. Clinical diagnosis of idiopathic Parkinson's disease confirmed by a Neurology specialist.
  • Hoehn and Yahr stage II or III. Functional walking ability. Clinically relevant lower-limb rigidity in at least one leg, defined as a score ≥2 on item 3.3d (right lower limb) or 3.3e (left lower limb) of Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
  • Stable antiparkinsonian pharmacological treatment during the previous 4 weeks, with no planned changes during the intervention period.
  • Ability to understand and follow simple instructions, defined as a score \>24 on the validated Spanish version of the Mini-Mental State Examination (MMSE-MEC).
  • Provision of written informed consent.

You may not qualify if:

  • Advanced Parkinson's disease, defined as Hoehn and Yahr stage \>III, with severe postural instability.
  • Other neurological or musculoskeletal conditions that could interfere with the assessment of lower-limb rigidity or gait.
  • Skin lesions, open wounds, or infection in the area where radiofrequency therapy will be applied.
  • Presence of a pacemaker, defibrillator, other implanted electronic device, or another contraindication to TECAR therapy, such as altered thermal sensitivity.
  • Lower-limb surgery within the previous 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociación Parkinson Aragón

Zaragoza, Zaragoza, 50015, Spain

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Paula Cordova-Alegre, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2026

First Posted

September 25, 2026

Study Start

September 21, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly shared because the approved study protocol does not include a specific plan for sharing individual-level data with external researchers. Study results will be reported in aggregated form to protect participant confidentiality and privacy.

Locations