The Effect of Telerehabilitation Based Pilates Training in Multiple Sclerosis Patients

NCT04838886 | Completed

• 1 other identifier: Gazi 2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterized by myelin, oligodendrocyte, and axon damage. MS usually begins with attacks due to demyelination of axons in the brain, optic nerve, and spinal cord; over time it develops into a neurodegenerative disease associated with neurotrophic support deficiency and neuronal loss. In MS, various loss of strength, balance, fatigue, cognitive and gait disturbances arise in the central nervous system due to sensory and/or motor neuron degeneration. These disorders affect the quality of life by limiting the individual's activities and participation in their daily lives. Therefore, it is important to treat these disorders in the treatment of MS. There are various pharmacological treatments and invasive procedures for the management of MS symptoms and one of the most commonly used treatment options is rehabilitation. Clinically-based exercise and rehabilitation are some of the most beneficial rehabilitation strategies in people with MS (PwMS). Clinically-based exercise and rehabilitation have been shown to stabilize or improve many physical symptoms of MS including loss of strength, balance dysfunction, impaired mobility, and fatigue. These benefits have led many practitioners to consider physical exercise as a nonpharmaceutical disease-modifying treatment. However, due to various factors such as mobility disorders, fatigue, and related problems, geographic location, time constraints, transportation difficulties, health insurance coverage, and financial burden, clinical-based exercise may be problematic in some pwMS. To overcome these challenges, approaches to rehabilitation have been developed such as telerehabilitation. The telerehabilitation system provides benefits such as continuity in patient education and rehabilitation, showing progress in rehabilitation, making changes in the treatment program, and saving individuals time and financial expenses. It is also an innovative and potential alternative to face-to-face interventions for treating disease-related disorders in pwMS. In literature, there are many studies examining the effectiveness of telerehabilitation in pwMS. According to these studies, ıt has been shown that telerehabilitation, with its technical facilities, had the potential to make clinical interventions widely accessible and effective for MS, however, telerehabilitation-based interventions could not replace traditional interventions but could perfectly complement. It has been found that telerehabilitation improved balance and postural control in MS patients and had no side effects. However, it was emphasized that the evidence levels of the studies were insufficient for methodological reasons. It has been determined additional studies are needed to investigate examining the effect on walking. Another clinical-based exercise method is Pilates. Pilates is a "core" stability-based exercise method that includes endurance, flexibility, movement, posture, and respiratory control. Studies have shown that Pilates training can improve balance, mobility, and muscle strength, fatigue in pwMS due to its structure consisting of balance and strengthening exercises. When the literature is reviewed in terms of Telerehabilitation based on Pilates in pwMS, it is seen that there are only two studies. In both studies, pwMS were given 20 minutes of yoga, 20 minutes of Pilates, and 20 minutes of dual-task exercise. However, these studies were in the project phase and the results are still not reported. On the other hand, in both studies, Pilates is given as combined training. As a result, telerehabilitation is an alternative method to MS treatment. In addition, while there are many clinical-based Pilates studies in the literature, telerehabilitation-based Pilates studies are insufficient. Telerehabilitation-based Pilates training studies are needed. Therefore, the investigators planned this study to investigate the effect of telerehabilitation-based pilates training on physical performance and quality of life in pwMS.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Pilates; Exercise; Telerehabilitation; Physical performance; Balance; Gait; Fatigue

Outcome Measures

Primary Outcomes (18)

• Dynamic Balance- Baseline

  Berg Balance Scale. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. (0 = worst,56 = best)

  Assessment will be conducted before the intervention

• Dynamic Balance-Post intervention

  Berg Balance Scale. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. (0 = worst,56 = best)

  Assessment will be conducted immediately after the intervention.

• Static Balance- Baseline

  Biodex Balance System

  Assessment will be conducted before the intervention.

• Static Balance- Post intervention

  Biodex Balance System

  Assessment will be conducted immediately after the intervention.

• An individual's confidence in performing activities- Baseline

  Activities-specific Balance Confidence Scale. Items are rated on a 0% to 100% whole number rating scale. (0 = worst,100 = best)

  Assessment will be conducted before the intervention.

• An individual's confidence in performing activities- Post intervention

  Activities-specific Balance Confidence Scale. Items are rated on a 0% to 100% whole number rating scale. (0 = worst,100 = best)

  Assessment will be conducted immediately after the intervention.

• Exercise capacity- Baseline

  Six minute walk test

  Assessment will be conducted before the intervention.

• Exercise capacity- Post intervention

  Six minute walk test

  Assessment will be conducted immediately after the intervention.

• Gait parameters- Baseline

  Wearable system (G-Walk)

  Assessment will be conducted before the intervention.

• Gait parameters- Post intervention

  Wearable system (G-Walk)

  Assessment will be conducted immediately after the intervention.

• Functional mobility- Baseline

  Timed up go test

  Assessment will be conducted before the intervention.

• Functional mobility- Post intervention

  Timed up go test

  Assessment will be conducted immediately after the intervention.

• Core endurance- Baseline

  Mcgill core endurance tests

  Assessment will be conducted before the intervention.

• Core endurance- Post intervention

  Mcgill core endurance tests

  Assessment will be conducted immediately after the intervention.

• Core strength- Baseline

  Mcgill core strength tests

  Assessment will be conducted before the intervention.

• Core strength-Post intervention

  Mcgill core strength tests

  Assessment will be conducted immediately after the intervention.

• Muscle Strength outcomes- Baseline

  Hand dynamometer (Baseline®, White Plains, New York, US)

  Assessment will be conducted before the intervention.

• Muscle Strength outcomes- Post intervention

  Hand dynamometer (Baseline®, White Plains, New York, US)

  Assessment will be conducted immediately after the intervention.

Secondary Outcomes (8)

• Physical activity level- Baseline

  Assessment will be conducted before the intervention.

• Physical activity level- Post intervention

  Assessment will be conducted immediately after the intervention.

• Fatigue severity- Baseline

  Assessment will be conducted before the intervention.

• Fatigue severity- Post intervention

  Assessment will be conducted immediately after the intervention.

• Impact of fatigue on activities- Baseline

  Assessment will be conducted before the intervention.

Study Arms (2)

Exercise group

EXPERIMENTAL

The intervention group will be received telerehabilitation-based pilates training three times a week for 6 weeks.

Other: Telerehabilitation-based Pilates Exercise

Waitlist

NO INTERVENTION

The control group will be a wait-list group without any additional specific treatment.

Interventions

Telerehabilitation-based Pilates Exercise OTHER

The group that will receive telerehabilitation-based pilates training via telerehabilitation

Exercise group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Voluntarily participate in research to accept
• Having a diagnosis of "Multiple Sclerosis" by a specialist physician
• Relapse free in the last 3 mounts
• An Expanded Disability Status Scale (EDSS) score less than or equal to 4

You may not qualify if:

• Any cardiovascular, orthopedic, visual, hearing, and perception problems that may affect the results of the research.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• Eldemir K, Guclu-Gunduz A, Eldemir S, Saygili F, Ozkul C, Irkec C. Effects of Pilates-based telerehabilitation on physical performance and quality of life in patients with multiple sclerosis. Disabil Rehabil. 2024 May;46(9):1807-1814. doi: 10.1080/09638288.2023.2205174. Epub 2023 May 6.

  PMID: 37147864 DERIVED

Related Links

• related info
• related info
• related info

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kader Eldemir, PT, MSc.

  Research Assistant

  STUDY CHAIR

• Arzu Güçlü-Gündüz, PT, PhD

  Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Intervention and control groups

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 9, 2021
• Study Start: April 15, 2021
• Primary Completion: May 15, 2022
• Study Completion: May 25, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)