Safety, Tolerability, and Acute Effects of Capacitive-Resistive Radiofrequency Therapy (TECAR) Applied to the Lower Limbs in People With Parkinson's Disease: An Experimental Within-Subject Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Lower-Limb Muscle Stiffness
研究概览
简要总结
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.
详细描述
This is an experimental, randomized-sequence, within-subject crossover study designed to evaluate the safety, tolerability, and acute effects of capacitive-resistive radiofrequency therapy (TECAR) applied to the lower limbs of people with Parkinson's disease.
Each participant will receive four TECAR treatment protocols in separate sessions: (1) capacitive mode for 15 minutes per leg; (2) resistive mode for 15 minutes per leg; (3) a mixed capacitive-resistive protocol consisting of 10 minutes of capacitive treatment followed by 5 minutes of resistive treatment per leg; and (4) a mixed resistive-capacitive protocol consisting of 10 minutes of resistive treatment followed by 5 minutes of capacitive treatment per leg. Treatment intensity will be individually adjusted to produce a clear but comfortable thermal effect.
The order of the four interventions will be randomized individually for each participant to minimize potential period, learning, and carryover effects. A washout period of at least 7 days will separate treatment sessions. Participants will continue their usual antiparkinsonian medication and usual medical care throughout the study. Assessments will be performed during the pharmacological "ON" state, approximately 60-90 minutes after the participant's usual dopaminergic medication.
The primary outcome will be lower-limb muscle stiffness measured objectively using MyotonPRO myotonometry. Measurements will be obtained from standardized anatomical sites, including the medial gastrocnemius, tibialis anterior, rectus femoris, and biceps femoris muscles.
Secondary outcomes will include functional mobility assessed with the Timed Up and Go test, walking speed assessed with the 10-Metre Walk Test, range of motion of the ankle, knee, and hip measured by goniometry, and lower-limb musculoskeletal pain assessed using a Numeric Rating Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Capacitive TECAR Therapy
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.
干预措施: Capacitive Radiofrequency Therapy (Other)
Resistive TECAR Therapy
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.
干预措施: Resistive Radiofrequency Therapy (Other)
Capacitive-Resistive TECAR Therapy
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.
干预措施: Capacitive-Resistive Radiofrequency Therapy (Other)
Resistive-Capacitive TECAR Therapy
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
干预措施: Resistive-Capacitive Radiofrequency Therapy (Other)
结局指标
主要结局
Change in Lower-Limb Muscle Stiffness
时间窗: Immediately before, immediately after, and 48 hours after each intervention session
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.
次要结局
- 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)