Multiple Sclerosis Clinical Trial
— MUSCLEOfficial title:
MUSCLE - Nordic and Free Walking in People With Multiple Sclerosis: Clinical-functional, Motor Control, and Gait Analysis Findings: a Randomized Controlled Multicentre Clinical Trials
Verified date | May 2022 |
Source | Federal University of Rio Grande do Sul |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is to analyze the effects of Nordic Walking and free walking in the clinical-functional, postural balance, motor control, muscular echographic quality, and gait analysis (pendulum gait mechanism), in people with Multiple Sclerosis.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | December 30, 2024 |
Est. primary completion date | December 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility | Inclusion Criteria: - volunteers aged over 20 years; - of both sexes; - with a clinical diagnosis of multiple sclerosis. Exclusion Criteria: - 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 | Universidade Federal do Rio Grande do Sul | Porto Alegre | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Leonardo A. Peyré-Tartaruga | Aline Nogueira Haas, Flávia Gomes Martinez |
Brazil,
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* Note: There are 46 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Balance Dynamics | Balance Dynamics: This outcome will be evaluated using Berg Balance Scale (BBS). This scale assessment of the individual's balance in 14 situations, representative of activities of the day to day, such as: stand up, get up, walk, to lean forward, to move, to turn, among others. The maximum score of a being reached of 56 points and each item has an ordinal scale of five alternatives ranging from 0 to 4 points, according to the degree of difficulty. | Change from baseline at 12 weeks | |
Other | Balance Static | Balance Static: This outcome will be evaluated using area of center of pressure (cm squared). | Change from baseline at 12 weeks | |
Other | Stride length | Stride Length (in meters). 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 at different speed of walking (SSWS, below and above of the SSWS), 3 minutes at each speed (in kilometers/hours). | Change from baseline at 12 weeks | |
Other | Dynamics Stability | This outcome is calculated as the inter-strides variation in terms of coefficient of variation of stride frequency. | Change from baseline at 12 weeks | |
Other | Electromyographic activity | This outcome is measure is the mean amplitude (in millivolts) of the muscles: vastus lateralis (VL), biceps femoris (BF), anterior tibial (AT) and medial gastrocnemius (MG) This outcome will be measured through Measuring the electromyographic activation during treadmill walking tests using an electromyograph. In of the walking test on treadmill at different speed of walking (SSWS, below and above of the SSWS), 3 minutes at each speed. | Change from baseline at 12 weeks | |
Other | Motor behavior by electromyographic activity | During the gait initiation, the investigators will evaluate the anticipatory 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 and free walking interventions. |
Change from baseline at 12 weeks | |
Other | Muscular activation | 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).
All these parameters will be measured before and after Nordic and free walking interventions. |
Change from baseline at 12 weeks | |
Other | Internal Work | 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.
All these parameters will be measured before and after Nordic and free walking interventions. |
Change from baseline at 12 weeks | |
Other | External Work | 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.
All these parameters will be measured before and after Nordic and free walking interventions. |
Change from baseline at 12 weeks | |
Other | total mechanical work | 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.
All these parameters will be measured before and after Nordic and free walking interventions. |
Change from baseline at 12 weeks | |
Other | Pendulum-like 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.
This parameter will be measured before and after Nordic and free walking interventions. |
Change from baseline at 12 weeks | |
Other | Scapular and pelvis coordination | 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 phases relation in angle. This parameter will be measured before and after Nordic and free walking interventions. |
Change from baseline at 12 weeks | |
Other | Range of motion | Range of motion (in degrees) of the following segments and joints: Tilt pelvic, sagittal flexion of trunk, hip flexion, knee flexion, ankle flexion, shoulder flexion, shoulder abduction, elbow flexion. All these parameters will be measured before and after Nordic and free walking interventions. | Change from baseline at 12 weeks | |
Other | Psychological parameters - Profile of Mood State | 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 (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 | |
Primary | Test Timed Up and Go | Test Timed Up and Go: This test evaluates the mobility functional in three meters of self-selected speed (TUGSS) or at forced speed (TUGFS) [Time Frame: Change from baseline at 12 weeks] | Change from baseline at 12 weeks | |
Primary | Locomotor Rehabilitation Index | The Locomotor Rehabilitation Index is a method of determining how close is the SSW compared to the Optimum Speed (Vopt). | Change from baseline at 12 weeks | |
Primary | Self-selected walking speed | SSWS This outcome will be measure in test of treadmill walking | Change from baseline at 12 weeks | |
Secondary | Optimal Walking Speed (OPT) | 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) | Quality of life (QoL) The quality of life will be estimated using the World Health Organization Quality of Life. (WHOQOL-short domains: physical, psychological, social relationships, environment, and general quality of life) and (WHOQOL-Long domains: sensory abilities, autonomy, Past. Present and Future Activities, social participation, death and dying, intimacy, and general quality of life). | Change from baseline at 12 weeks | |
Secondary | Cognitive function | Cognitive function This outcome will be measure for Montreal Cognitive Assessment (MoCA). | 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 patient 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 | |
Secondary | Expanded Disability Status Scale | The Expanded Disability Status Scale is the most appropriate to assess evolution and point to a new relapse. The Expanded Disability Status Scale has been the most commonly used. It has twenty items with scores ranging from 0 to 10, with the score increasing by half a point according to the patient's degree of disability, giving more focus on the patient's ability to walk (especially in scores above 4.0). | Change from baseline at 12 weeks |
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