Plantar Sensitivity Training and Aerobic Exercise Training in Patients With Multiple Sclerosis (PlaSTAcET Study)
NCT ID: NCT05937971
Last Updated: 2023-09-28
Study Results
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Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2023-09-01
2024-08-01
Brief Summary
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H0 hypothesis: Plantar sensory training given in addition to aerobic exercise training in patients with multiple sclerosis has no additional contribution to balance, functional capacity, walking and proprioception.
H1 hypothesis: Plantar sensory training given in addition to aerobic exercise training in patients with multiple sclerosis has an additional contribution to balance, functional capacity, walking and proprioception.
Conventional exercises (with the addition of warm-up and cool-down periods) will be applied to all multiple sclerosis patients participating in the study; In addition, aerobic exercise training will be given. In addition to these exercises, plantar sensory training will be given to the sensory training group. Exercises and plantar sensory training will be given to the participants at intervals of three weeks, with progressively progressive sessions, 2 days a week for 12 weeks. Patients will be evaluated twice, before treatment and at the end of treatment 12 weeks later. Within the scope of the evaluation, balance, functional capacity, gait, proprioception and plantar sensory parameters will be measured in patients. As a result of the study, it will be examined whether plantar sensory training given in addition to aerobic exercise training in multiple sclerosis patients has an additional contribution to balance, functional capacity, walking and proprioception. There is no study in the literature examining the effects of plantar sensory training and aerobic exercise training on balance, functional capacity, walking and proprioception in patients with multiple sclerosis. In this respect, it is anticipated that the study will contribute to the literature.
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Detailed Description
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Multiple sclerosis is a chronic progressive neurodegenerative disease that causes damage to neural structures such as myelin sheath, oligodendrocytes, and axons in the central nervous system. In addition to motor, cognitive, cerebellar, visual and brain stem functions, sensory functions are also affected in patients with multiple sclerosis. Loss of deep and superficial senses, dysesthesia and paresthesias can be given as examples of these sensory dysfunctions. It is known that plantar cutaneous sensory information provides important clues in maintaining balance, and disturbances in sensory information for any reason cause postural oscillations. Therefore, it is thought that sensory dysfunction in patients with multiple sclerosis may be related to deficits in maintaining static and dynamic balance. There are limited studies on the positive effects of plantar sensory manipulations on balance in different patient populations.
The decrease in aerobic capacity in patients with multiple sclerosis may affect parameters such as balance, walking, and sensory functions. Due to these effects, activity limitations, decreased walking distance, falls, and injuries related to falling may occur in patients. It has been shown that aerobic exercise training increases functional capacity in patients with multiple sclerosis and deep senses such as proprioception and vibration in different patient groups. In this direction, the aim of the thesis study is to examine whether plantar sensory training given in addition to aerobic exercise training has an additional contribution to balance, functional capacity, walking and proprioception in patients with multiple sclerosis.
There is no study in the literature examining the effects of plantar sensory training and aerobic exercise training on balance, functional capacity, walking and proprioception in patients with multiple sclerosis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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plantar sensitivity training group
Conventional exercises (with the addition of warm-up and cool-down periods) will be applied to all multiple sclerosis patients participating in the study; In addition, aerobic exercise training will be given. In addition to these exercises, plantar sensory training will be given to the sensory training group. Exercises and plantar sensory training will be given to the participants at intervals of three weeks, with progressively progressive sessions, 2 days a week for 12 weeks. Patients will be evaluated twice, before treatment and at the end of treatment 12 weeks later. Within the scope of the evaluation, balance, functional capacity, gait, proprioception and plantar sensory parameters will be measured in patients.
plantar sensitivity training
Plantar sensory training protocol:
Applying a moisturizing cream by washing the feet with warm water and drying them (before coming to the session)
Dynamic gastro-soleus stretching (20 sec, 5 reps, 2 min)
Plantar fascia stretch (20 sec, 5 reps, 2 min)
Picking up sheets with feet (10 reps, 2 min)
Pushing the small roller under the foot back and forth (10 reps, 2 min)
Holding the spiny proprioception ball on the plantar surface of the foot while sitting, moving it in anterior-posterior and circular directions (2x2.5 min=5 min)
Keeping the carpet pieces of different softness and texture on the plantar surface of the foot and moving them in anterior-posterior and circular directions (2x2.5 min=5 min) Soft tissue mobilizations applied to the soles of the feet by the physiotherapist (2 minutes)
aerobic exercise training
Warm-up exercises; will consist of stretching exercises (20-30 s, 5 repetitions), breathing exercises (6-10 s, 5 repetitions) and range of motion exercises (8-10 s, 5 repetitions) for the whole body. Conventional exercises will include balance (10 s, 5 reps), coordination (5-10 s, 5 reps), stabilization (5-10 s, 5 reps) and strengthening exercises (8-10 s, 5 reps), specific to each patient. Aerobic exercise training was started at 40% of the maximum heart rate on the treadmill and gradually increased at three-week intervals (40% in weeks 1-3, 50% in weeks 4-6, 60% in weeks 7-9, and 70% in weeks 10-12). ) will be progressed. Cool-down exercises will include a gradual lowering of the treadmill speed (3 min) and ankle range of motion exercises. Plantar sensory training begins with a duration of 5 minutes and progresses from a sitting position to a standing position at three-week intervals (1-3 weeks 5 minutes, 4-6 weeks 10 minutes, 7-9 weeks 15 minutes, 10-12 weeks 20 minutes). will be.
aerobic exercise training group
Conventional exercises (with the addition of warm-up and cool-down periods) will be applied to all multiple sclerosis patients participating in the study; In addition, aerobic exercise training will be given. In addition to these exercises, plantar sensory training will be given to the sensory training group. Exercises and plantar sensory training will be given to the participants at intervals of three weeks, with progressively progressive sessions, 2 days a week for 12 weeks. Patients will be evaluated twice, before treatment and at the end of treatment 12 weeks later. Within the scope of the evaluation, balance, functional capacity, gait, proprioception and plantar sensory parameters will be measured in patients.
aerobic exercise training
Warm-up exercises; will consist of stretching exercises (20-30 s, 5 repetitions), breathing exercises (6-10 s, 5 repetitions) and range of motion exercises (8-10 s, 5 repetitions) for the whole body. Conventional exercises will include balance (10 s, 5 reps), coordination (5-10 s, 5 reps), stabilization (5-10 s, 5 reps) and strengthening exercises (8-10 s, 5 reps), specific to each patient. Aerobic exercise training was started at 40% of the maximum heart rate on the treadmill and gradually increased at three-week intervals (40% in weeks 1-3, 50% in weeks 4-6, 60% in weeks 7-9, and 70% in weeks 10-12). ) will be progressed. Cool-down exercises will include a gradual lowering of the treadmill speed (3 min) and ankle range of motion exercises. Plantar sensory training begins with a duration of 5 minutes and progresses from a sitting position to a standing position at three-week intervals (1-3 weeks 5 minutes, 4-6 weeks 10 minutes, 7-9 weeks 15 minutes, 10-12 weeks 20 minutes). will be.
Interventions
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plantar sensitivity training
Plantar sensory training protocol:
Applying a moisturizing cream by washing the feet with warm water and drying them (before coming to the session)
Dynamic gastro-soleus stretching (20 sec, 5 reps, 2 min)
Plantar fascia stretch (20 sec, 5 reps, 2 min)
Picking up sheets with feet (10 reps, 2 min)
Pushing the small roller under the foot back and forth (10 reps, 2 min)
Holding the spiny proprioception ball on the plantar surface of the foot while sitting, moving it in anterior-posterior and circular directions (2x2.5 min=5 min)
Keeping the carpet pieces of different softness and texture on the plantar surface of the foot and moving them in anterior-posterior and circular directions (2x2.5 min=5 min) Soft tissue mobilizations applied to the soles of the feet by the physiotherapist (2 minutes)
aerobic exercise training
Warm-up exercises; will consist of stretching exercises (20-30 s, 5 repetitions), breathing exercises (6-10 s, 5 repetitions) and range of motion exercises (8-10 s, 5 repetitions) for the whole body. Conventional exercises will include balance (10 s, 5 reps), coordination (5-10 s, 5 reps), stabilization (5-10 s, 5 reps) and strengthening exercises (8-10 s, 5 reps), specific to each patient. Aerobic exercise training was started at 40% of the maximum heart rate on the treadmill and gradually increased at three-week intervals (40% in weeks 1-3, 50% in weeks 4-6, 60% in weeks 7-9, and 70% in weeks 10-12). ) will be progressed. Cool-down exercises will include a gradual lowering of the treadmill speed (3 min) and ankle range of motion exercises. Plantar sensory training begins with a duration of 5 minutes and progresses from a sitting position to a standing position at three-week intervals (1-3 weeks 5 minutes, 4-6 weeks 10 minutes, 7-9 weeks 15 minutes, 10-12 weeks 20 minutes). will be.
Eligibility Criteria
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Inclusion Criteria
* Being diagnosed with multiple sclerosis according to McDonald's criteria
* EDSS (Expanded Disability Status Scale) score between 3 and 5.5
* Stage 3/4/5 according to functional ambulation classification
* Being able to ambulatory 100 meters independently or with device assistance
* Not having an attack in the last 3 months
* No change in routine treatment for MS (multiple sclerosis) in the past 3 months
* Presence of plantar sensitivity loss (as measured with Semmes-Weinstein monofilaments)
* having a plantar sensory threshold value higher than 2,83-3.61 for 1st metatarsal head;
* 2.83-3.61 for 2-3rd metatarsal heads;
* 2.83-3.61 for 4-5th metatarsal heads;
* 3.61-4.08 for the lateral and medial heel)(15)
* Decreased functional capacity (6-minute walking test distance F\<593±57meters, M\<638±44meters) (16)
Exclusion Criteria
* having diabetic neuropathy
* Having neurological disease other than multiple sclerosis
* Having a diagnosis of root compression, radiculopathy, lumbar disc herniation or complaining of low back pain for the last 3 months(17)
* Using an ankle-foot orthosis (AFO)
* Having cognitive dysfunction (MoCA score \<21)
18 Years
65 Years
ALL
No
Sponsors
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Istanbul University - Cerrahpasa
OTHER
Istanbul Arel University
OTHER
Responsible Party
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NAZLI GÜNGÖR
Lecturer, Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences
Principal Investigators
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Nazlı Güngör, PT, MSc
Role: PRINCIPAL_INVESTIGATOR
Istanbul Arel University
Locations
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Istanbul Arel University
Istanbul, Zeytinburnu, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Homayuni A, Hosseini Z. Correction: An intervention design for promoting quality of life among patients with multiple sclerosis: a protocol with a planning approach for a mixed methods study. BMC Neurol. 2023 Feb 6;23(1):61. doi: 10.1186/s12883-023-03103-y. No abstract available.
Monaghan AS, Huisinga JM, Peterson DS. The relationship between plantar sensation and muscle onset during automatic postural responses in people with multiple sclerosis and healthy controls. Mult Scler Relat Disord. 2021 Nov;56:103313. doi: 10.1016/j.msard.2021.103313. Epub 2021 Oct 5.
Song Q, Zhang X, Mao M, Sun W, Zhang C, Chen Y, Li L. Relationship of proprioception, cutaneous sensitivity, and muscle strength with the balance control among older adults. J Sport Health Sci. 2021 Sep;10(5):585-593. doi: 10.1016/j.jshs.2021.07.005. Epub 2021 Jul 20.
Peebles AT, Bruetsch AP, Lynch SG, Huisinga JM. Dynamic Balance Is Related to Physiological Impairments in Persons With Multiple Sclerosis. Arch Phys Med Rehabil. 2018 Oct;99(10):2030-2037. doi: 10.1016/j.apmr.2017.11.010. Epub 2017 Dec 22.
Kalron A, Pasitselsky D, Greenberg-Abrahami M, Achiron A. Do textured insoles affect postural control and spatiotemporal parameters of gait and plantar sensation in people with multiple sclerosis? PM R. 2015 Jan;7(1):17-25. doi: 10.1016/j.pmrj.2014.08.942. Epub 2014 Aug 19.
Naka T, Hayashi T, Sugyo A, Watanabe R, Towatari F, Maeda T. The effects of lower extremity deep sensory impairments on walking capability in patients with incomplete cervical spinal cord injury. J Spinal Cord Med. 2022 Mar;45(2):287-292. doi: 10.1080/10790268.2020.1788879. Epub 2020 Jul 23.
Parsons SL, Mansfield A, Inness EL, Patterson KK. The relationship of plantar cutaneous sensation and standing balance post-stroke. Top Stroke Rehabil. 2016 Oct;23(5):326-32. doi: 10.1080/10749357.2016.1162396. Epub 2016 Mar 31.
Khalifeloo M, Naghdi S, Ansari NN, Akbari M, Jalaie S, Jannat D, Hasson S. A study on the immediate effects of plantar vibration on balance dysfunction in patients with stroke. J Exerc Rehabil. 2018 Apr 26;14(2):259-266. doi: 10.12965/jer.1836044.022. eCollection 2018 Apr.
Chisholm AE, Qaiser T, Williams AMM, Eginyan G, Lam T. Acquisition of a precision walking skill and the impact of proprioceptive deficits in people with motor-incomplete spinal cord injury. J Neurophysiol. 2019 Mar 1;121(3):1078-1084. doi: 10.1152/jn.00432.2018. Epub 2019 Feb 6.
Langeskov-Christensen M, Heine M, Kwakkel G, Dalgas U. Aerobic capacity in persons with multiple sclerosis: a systematic review and meta-analysis. Sports Med. 2015 Jun;45(6):905-23. doi: 10.1007/s40279-015-0307-x.
Van Geel F, Bielen H, Theunissen K, Moumdjian L, Van Nieuwenhoven J, Van Wijmeersch B, Meesen R, Ramari C, Feys P. Clinical manifestation and perceived symptoms of walking-related performance fatigability in persons with multiple sclerosis. Int J Rehabil Res. 2021 Jun 1;44(2):118-125. doi: 10.1097/MRR.0000000000000457.
Latimer-Cheung AE, Pilutti LA, Hicks AL, Martin Ginis KA, Fenuta AM, MacKibbon KA, Motl RW. Effects of exercise training on fitness, mobility, fatigue, and health-related quality of life among adults with multiple sclerosis: a systematic review to inform guideline development. Arch Phys Med Rehabil. 2013 Sep;94(9):1800-1828.e3. doi: 10.1016/j.apmr.2013.04.020. Epub 2013 May 10.
Dixit S, Maiya A, Shastry BA. Effects of Aerobic Exercise on Vibration Perception Threshold in Type 2 Diabetic Peripheral Neuropathy Population Using 3-sites Method: Single-blind Randomized Controlled Trial. Altern Ther Health Med. 2019 Mar;25(2):36-41.
Burcal CJ, Wikstrom EA. Plantar Cutaneous Sensitivity With and Without Cognitive Loading in People With Chronic Ankle Instability, Copers, and Uninjured Controls. J Orthop Sports Phys Ther. 2016 Apr;46(4):270-6. doi: 10.2519/jospt.2016.6351. Epub 2016 Jan 26.
Chetta A, Zanini A, Pisi G, Aiello M, Tzani P, Neri M, Olivieri D. Reference values for the 6-min walk test in healthy subjects 20-50 years old. Respir Med. 2006 Sep;100(9):1573-8. doi: 10.1016/j.rmed.2006.01.001. Epub 2006 Feb 7.
Vaitkus A, Sipylaite J. Sensory Perception in Lumbosacral Radiculopathy with Radicular Pain: Feasibility Study of Multimodal Bedside-Suitable Somatosensory Testing. Acta Med Litu. 2021;28(1):97-111. doi: 10.15388/Amed.2021.28.1.18. Epub 2021 Apr 29.
Other Identifiers
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PlaSTAcET
Identifier Type: -
Identifier Source: org_study_id
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