Plantar Sensitivity Training and Aerobic Exercise Training in Patients With Multiple Sclerosis (PlaSTAcET Study)

Multiple Sclerosis Clinical Trial

Official title:

Examination of the Implications of Plantar Sensitivity Training and Aerobic Exercise Training on Balance, Functional Capacity, Gait and Proprioception in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05937971
• Other study ID #: PlaSTAcET
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: September 2023
• Source: Istanbul Arel University
• Contact: Nazli Güngör, PT, MSc
• Phone: +905398659517
• Email: nazligungor[@]arel.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this 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. In this direction, the hypotheses of the study are stated below. 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.

Description:

The aim of this 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• being between the ages of 18-65
• 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:

• Being diagnosed with pulmonary, orthopedic or cardiovascular disease
• 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)

Related Conditions & MeSH terms

• Hypersensitivity
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul Arel University	Istanbul	Zeytinburnu

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul Arel University	Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (16)

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 — View Citation

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. — View Citation

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.0043 — View Citation

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. — View Citation

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- — View Citation

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 — View Citation

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. eCo — View Citation

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. — View Citation

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 — View Citation

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.msar — View Citation

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: 10.1080/107 — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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 — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	plantar sensitivity measurement	from 1st metatarsal head, 2nd-3rd. metatarsal head, 4-5. metatarsal head, medial calcaneus, lateral calcaneus points (with Semmes-Weinstein monofilaments)	Change from before treatment at 12 weeks of intervention/treatment
Primary	Balance measurement (One-leg standing test(seconds))	The participant will be asked to stand on one leg while the other's knee is in 90° flexion. The stopwatch will be recorded time in seconds. The test will be terminated if the subject's upper foot touches the ground. Separate measurements are made for both extremities.	Change from before treatment at 12 weeks of intervention/treatment
Primary	Balance measurement (measurement of spatiotemporal parameters of balance (with baropodometry) -Bipedal 30 seconds oscillation amplitude (mm)	This measurement will be performed with a baropodometry. The patient is asked to stand on the baropodometry platform surface with both feet. Postural sways will be recorded and it demonstrates the sum of deviations from the center of mass.	Change from before treatment at 12 weeks of intervention/treatment
Primary	Balance measurement (measurement of spatiotemporal parameters of balance (with baropodometry)-Maximum oscillating amplitude (mm)	This measurement will be performed with a baropodometry. The patient is asked to stand on the baropodometry platform surface with both feet. Postural sways will be measured and the maximum deviation from the center of mass will be recorded.	Change from before treatment at 12 weeks of intervention/treatment
Primary	Balance measurement (measurement of spatiotemporal parameters of balance (with baropodometry)-Average oscillation rate (mm/s)	This measurement will be performed with a baropodometry. The patient is asked to stand on the baropodometry platform surface with both feet. Postural sways will be measured and the average deviation rate from the center of mass will be recorded.	Change from before treatment at 12 weeks of intervention/treatment
Primary	gait measurement (-timed 25-foot walk test)	The T25-FW (timed 25-foot walk test) is a quantitative mobility and leg function performance test based on a timed 25-walk. It is the first component of the MSFC (Multiple Sclerosis Functional Composite) to be administered at each visit. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task.	Change from before treatment at 12 weeks of intervention/treatment
Primary	gait measurement(spatiotemporal parameters of gait (with baropodometry) -stride length (mm))	This measurement will be performed with a baropodometry. The patient is asked to walk on the baropodometry platform surface. Stride length will be measured and recorded.	Change from before treatment at 12 weeks of intervention/treatment
Primary	gait measurement spatiotemporal parameters of gait (with baropodometry) -Bilateral maximum pressure (gr/cm2)	This measurement will be performed with a baropodometry. The patient is asked to walk on the baropodometry platform surface. The maximum pressure of both feet will be separately measured and recorded.	Change from before treatment at 12 weeks of intervention/treatment
Primary	gait measurement spatiotemporal parameters of gait (with baropodometry) -Bilateral mean pressure (gr/cm2)	This measurement will be performed with a baropodometry. The patient is asked to walk on the baropodometry platform surface. The average pressure of both feet will be separately measured and recorded.	Change from before treatment at 12 weeks of intervention/treatment
Primary	gait measurement (spatiotemporal parameters of gait (with baropodometry) -Right-left load distribution (%) (from five different points: 1st metatarsal head, 2nd-3rd metatarsal head, 4th-5th metatarsal head, heel medial, heel lateral)	This measurement will be performed with a baropodometry. The patient is asked to walk on the baropodometry platform surface. Right-left foot load distribution from five different points (1st metatarsal head, 2nd-3rd metatarsal head, 4th-5th metatarsal head, heel medial, heel lateral) will be separately measured and recorded.	Change from before treatment at 12 weeks of intervention/treatment
Secondary	functional capacity measurement	6-minute walk test	Change from before treatment at 12 weeks of intervention/treatment
Secondary	proprioception measurement (-Ankle position sensation)	Passive motion detection threshold test will be performed with a digital goniometer.	Change from before treatment at 12 weeks of intervention/treatment
Secondary	proprioception measurement (-Sensation of ankle kinesthesia)	Joint position reproduction test will be performed with a digital goniometer.	Change from before treatment at 12 weeks of intervention/treatment