Parkinson Disease Clinical Trial
Official title:
Effects of Different Physical Therapies and Dance on Clinical and Functional Parameters, Muscle Quality, Pendular Mechanism of the Gait and Brain-derived Neurotrophic Factor in People With Parkinson's Disease
Verified date | June 2020 |
Source | Federal University of Rio Grande do Sul |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of study is to analyze the effects of different physical therapies (Aquatic Jogging, Neurofunctional Physiotherapy, Pilates Training and Nordic Walking) and Dance and compare with unsupervised home exercises in the clinical-functional parameters, postural balance, muscular echographic quality, pendulum gait mechanism, and serum levels of BDNF in people with Parkinson's disease with camptocormia or Pisa Syndrome.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | December 30, 2022 |
Est. primary completion date | July 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Volunteers - aged over 40 years - both sexes - clinical diagnosis of idiopathic PD - PD staging between 1 and 4 in Hoehn and Yahr Scale (H&Y). Exclusion Criteria: - performing recent surgeries, deep brain stimulation (DBS - Deep Brain Stimulations); - severe heart diseases, uncontrolled hypertension, myocardial infarction within a period of less than one year, being a pacemaker; - stroke or other associated neurological diseases; insanity; - prostheses in the lower limbs; - without ambulation conditions. |
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of Rio Grande do Sul | Porto Alegre | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Federal University of Rio Grande do Sul | Aline Nogueira Haas, Flávia Gomes Martinez |
Brazil,
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* Note: There are 32 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Motor symptoms | This outcome will be evaluated using Unified Parkinson's Disease Rating Scale (UPDRS). This Scale the clinician-scored monitored motor evaluation. Will be to considered 30% improvement in motor symptoms has been applied to identify "responsive people". The score in each item ranges from 0 to 4, and the indicates greater impairment by the disease and the minimum, normality. The 14 items in the motor vehicle (the numbering of which goes from 18 to 31). | Change from baseline at 12 weeks. | |
Other | Freezing of Gait | The freezing of gait questionnaire (FOG-Q) has 6 questions and a total score of 0 to 24. A higher score corresponds to the more severe presence of freezing of gait and a lower score is equivalent to a lower presence or absence of freezing of gait . | Change from baseline at 12 weeks. | |
Other | Balance Static | The force platform will be used for the anteroposterior displacement of the center of pressure (COP)- COPx (in centimeters) and mediolateral - COPy (in centimeters) of the pressure center. | Change from baseline at 12 weeks. | |
Other | Spatial Parameter - Stride length | This outcome is measure by stride length in meters. This parameter will be measure before and after the nordic walking, dance and jogging aquatic interventions. | Change from baseline at 12 weeks. | |
Other | Temporal Parameter - Swing time, contact time, time of balance | Swing time in seconds, contact time in seconds, time of balance in seconds. The percentage of contact time will be calculated to measure the duty factor in percentual. The swing and contact time in seconds will be aggregated to distance in meters to arrive at frequency (in Hetz). These parameters will be measure before and after the nordic walking, dance and jogging aquatic interventions. |
Change from baseline at 12 weeks. | |
Other | Anthropometric data - Body mass | Body mass will be measure in kilograms before and after the nordic walking, dance and jogging aquatic interventions. These data will be measured in scale, stadiometer and anthropometric tape. All this parameters will be measure before and after the nordic walking, dance and jogging aquatic interventions. |
Change from baseline at 12 weeks. | |
Other | Anthropometric data - Height | Height will be measure in meters before and after the nordic walking, dance and jogging aquatic interventions. | Change from baseline at 12 weeks. | |
Other | Anthropometric data - Circumference | Circumference of body will be measure in centimeters before and after the nordic walking, dance and jogging aquatic interventions. | Change from baseline at 12 weeks. | |
Other | Anthropometric data - Body Mass Index | Weight and height will be combined to report the body mass index in kg/m2. This parameter will be measure before and after the nordic walking, dance and jogging aquatic interventions. | Change from baseline at 12 weeks. | |
Other | Electromyographic Parameters | This outcome is measure is a composite for: mean amplitude, onset, offset and time of the signal and co-contraction of the muscles: vastus lateralis (VL), biceps femoris (BF), anterior tibial (AT) and medial gastrocnemius (MG) all variables in percentage. This outcome will be measured through measuring the electromyographic activation during treadmill walking tests using an electromyograph. | Change from baseline at 12 weeks. | |
Other | Parameters of Pendular Mechanism - Internal Work | The transduction between the potential and kinetic mechanical energies of the center of body mass (called the "inverted pendulum" mechanism). The internal work is the mechanical energy fluctuations of the movement of limbs relative to the center of body mass (Wint, in Joules). This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill. | Change from baseline at 12 weeks. | |
Other | Parameters of Pendular Mechanism: external work | The transduction between the potential and kinetic mechanical energies of the center of body mass (called the "inverted pendulum" mechanism). The external work is energy fluctuations of the center of body mass with respect to the external environment or surroundings (Wext, in Joules). This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill. | Change from baseline at 12 weeks. | |
Other | Parameters of Pendular Mechanism: total mechanical work | The transduction between the potential and kinetic mechanical energies of the center of body mass (called the "inverted pendulum" mechanism). The total mechanical work (Wtot =Wext + Wint) produced by a body during activity. These outcomes are measured by composite for:(external, internal mechanical work, in Joules). This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill. | Change from baseline at 12 weeks. | |
Other | Parameters of Pendular Mechanism: Recovery | The mechanical energy exchange of the center of mass is quantified by the calculation of the percentage of reconversion of mechanical energy, called Recovery (R), which counts the form that the mechanical energy is saved through the pendulum mechanism of the locomotion. This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill. | Change from baseline at 12 weeks. | |
Other | Motor behavior by electromyographic activity | During the gait initiation, sit-to-stand movement and go up and down one step, the investigators will evaluate the anticipatory postural adjustments and compensatory postural adjustments. The electromyograph will be used to obtain electromyographic activity data of the spinal erector muscles, internal oblique, gluteus medius, rectus femoris, femoral biceps, medial gastrocnemius and tibialis anterior (in mV). All these parameters will be measured before and after Nordic walking, dance and jogging interventions. |
Change from baseline at 12 weeks. | |
Other | Muscular activation | Muscular activation during phases of the gait cycle of people with Parkinson's disease through the electromyographic evaluation of the muscles of the spinal erector, internal oblique, gluteus medius, rectus femoris, femoral biceps, anterior tibialis and medial gastrocnemius during treadmill running. All participants will walk on a treadmill at selected walking speed. To identify electromyographic activity during the different gait cycles, the electromyograph will be synchronized with VICON (Vicon Motion Capture System - Oxford - USA, 1984). | Change from baseline at 12 weeks. | |
Other | Scapular and pelvis coordination parameters | The scapular girdle movement in angles will be measure, pelvic girdle in angles will be measure. The scapular girdle movement in angles will be aggregated to pelvic girdle in angles to arrive at continuous and discrete phases coordinations in angles. All these parameters will be measure before and after the nordic walking, dance and jogging aquatic interventions. |
Change from baseline at 12 weeks. | |
Other | Angular variables | Tilt pelvic in angle, flexion and extension of trunk in angle, flexion and extension of hip in angle, flexion and extension of knee in angle, flexion and extension of ankle in angle, flexion and extension of shoulder in angle, abduction of shoulder in angle, flexion and extension of elbow in angle. All these angles variables will be measure in right and left limbs. Flexion and extension of shoulder in angle, abduction of shoulder in angle will be aggregated to flexion and extension of elbow in angle to arrive at asymmetry of upper limbs in angles. Maximum flexion and extension angles of trunk, hip, knee, ankle, shoulder and elbow; Maximum and minimum abduction of shoulder. Range of motion of the trunk (in the sagittal plane) and pelvic and scapular (in the transverse plane) girdle. |
Change from baseline at 12 weeks. | |
Other | Body Composition - Bone mineral density. | The body composition of the patient will be analyzed using the dual-energy X-ray absorptiometry (DEXA - Lunar Prodigy GE model Medical System, Milwaukee, WI, USA). The patient will be lying down in the 10 to 12 minutes until the test is complete. To prevent the movement of the lower limbs during passage of the reading rod of the velcro around the ankles and thighs. The patient can wear normal clothes as long as they have no metal charges or attachments. |
Change from baseline at 12 weeks. | |
Other | Psychological parameters - Profile of Mood State | Profile of Mood States: This variable will be measure by the Brunel Mood Scale (BRUMS) that was developed to provide a quick assessment of mood states adult populations. The BRUMS has been demonstrated to have Cronbach alpha values above 0.70 and is a reliable tool used to measure the mood of Brazilian athletes. The instrument consisted of 24 items and six subscales assessing mood: tension, depression, anger, vigor, fatigue and confusion. Each item was rated on a Likert scale ranging from nothing (0) to extremely (4), where the respondent indicated how they were feeling at that moment. The results were calculated using the mean of the items in each subscale. | Change from baseline at 12 weeks. | |
Other | Quality of sleep - The Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 24 questions or items to be rated (0-3 for 20 items while 4 items are open-ended), 19 of which are self-reported and 5 of which require secondary feedback from a room or bed partner. Only the self-reported items (15 rated as 0-3 while 4 open-ended) are used for quantitative evaluation of sleep quality as perceived by the patient. The open-ended items are also finally scored as structured categorical values (rated at 0-3) as per the range of values reported for them by the patient. These 19 self-reported items are used to generate categorical scores representing the PSQI's 7 components. The individual component scores each assess a specific feature of sleep. Finally, the scores for each component are summed to get a total score, also termed the global score (range: 0 to 21). This score provides a summary of the respondent's sleep experience and quality for the past month. | Change from baseline at 12 weeks. | |
Other | Nominal verbal fluency | Nominal verbal fluency evaluates verbal fluency, executive function, language, and semantic memory. The test consists in naming the largest number of words beginning with the letters "F", "A" and "S" in one minute each, excluding proper names. | Change from baseline at 12 weeks. | |
Primary | Test Timed Up and Go | Test Timed Up and Go This teste evaluate the mobility functional in three meters of self-selected speed (TUGSS) or at forced speed (TUGFS). | Change from baseline at 12 weeks. | |
Secondary | Locomotor Rehabilitation Index | The Locomotor Rehabilitation Index (LRI) is a method of determining how close is the self-selected walking speed compared to the Optimum Speed. The results is given in %, and when LRI value is closer to 100 %, it indicates that the participants are closer to their theoretical optimal walking speed. | Change from baseline at 12 weeks. | |
Secondary | Self-selected walking speed | SSWS This outcome will be measure in test of walking treadmill. | Change from baseline at 12 weeks. | |
Secondary | Optimal Walking Speed (OPT) | This outcome will be measure through of the registered image movement analysis using the three-dimensional motion analysis system (VICON) of the walking test on treadmill. | Change from baseline at 12 weeks. | |
Secondary | Quality of life (QoL): PDQ-39 | The quality of life will be measured by the Parkinson's Disease Questionnaire, with 39 questions (PDQ-39). PDQ-39 is a PD specific health status questionnaire comprising 39 items. Respondents are requested to affirm one of five ordered response categories according to how often, due to their PD, they have experienced the problem defined by each item. The total scores are ranging between 0 and 100 points, that a lower score represents a greater perception of quality of life. | Change from baseline at 12 weeks. | |
Secondary | Cognitive function - Montreal Cognitive Assessment | Montreal Cognitive Assessment (MoCA) is a brief screening tool for mild cognitive impairment. This evaluation accesses different cognitive domains and investigates the individual's abilities in the following areas: attention and concentration, executive functions, memory, language, visuoconstructive skills, conceptualization, calculation and orientation. The total score of the MoCA is 30 points, with a score of 26, or more, considered normal and less than 26 is considered cognitive impairment. | Change from baseline at 12 weeks. | |
Secondary | Cognitive function - Mini Mental State Examination | Mini-Mental State Examination (MMSE) is a screening tool, used to identify dementia, which provides information on different cognitive parameters, containing questions grouped into seven categories that assess specific cognitive functions: temporal orientation, spatial orientation, three word registration, attention and calculation, recall of three words, language and visual constructive ability. The MMSE score can range from zero to 30 points, in which a lower score indicates a higher degree of cognitive impairment. | Change from baseline at 12 weeks. | |
Secondary | Depressive symptoms | This outcome will be measure for the Geriatric Depression Scale - 15 item. The scale consists of 15 dichotomous questions in which participants are asked to answer yes or no in reference to how they felt over the past week (for instance, "Do the pacient feel that their life is empty?," Do the patient feel that their situation is hopeless?). Scores range from 0 to 15 with higher scores indicating more depressive symptoms. | Change from baseline at 12 weeks. |
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