Closed Kinetic Chain Exercises for Balance and Gait Rehabilitation for People With MS

NCT05460299 | Unknown DMC

• 1 other identifier: SREC/22/05/043
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

In total, 27 patients with MS (Expanded Disability Status Scale (EDSS) score equal to or less than 5.5) were randomly assigned to either Telko plus conventional physical therapy (CPT) experimental group (n=14) or the CPT control group (n=13). All patients received 15-minute CPT, three times a week, for four weeks. The patients in the experimental group received 15-minute Telko at the end of each CPT session. The outcome measures used were the Berg Balance Scale (BBS), 6-Minute Walk Test (6MWT), and Timed Up and Go (TUG) assessment.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• 6-minute walk test (6-MWT)

  The 6-MWT was used to assess functional capacity in people with MS (Goldman et al., 2008). It measures the distance covered by the patient in 6 minutes (Goldman et al., 2008). It is a good predictor of cardiorespiratory endurance in patients with MS (Goldman et al., 2008). The 6-MWT for people with MS has shown good reliability (ICC = 0.96-0.98) and good discriminant validity (Bartels et al., 2012; De Groot \& Takken, 2011). The 6-MWT for people with MS has revealed good reliability (ICC = 0.96-0.98) and good validity (Bartels et al., 2012; De Groot \& Takken, 2011). The test was administrated according to the guidelines provided by of American Thoracic Society (ATS) (ATS Statement, 2002). Two canes were placed 30 meters from each other. Before and immediately after the test, heart rate and oxygen saturation were documented using a pulse oximeter. The participant was able to complete the 6-MWT without taking a rest break.

  Change from baseline 6-minute walk test at 4-week

• Berg Balance Scale (BBS)

  Balance was evaluated using the BBS. It has excellent reliability (ICC = 0.986) in people with MS (Cattaneo et al., 2007). This scale contains 14 items instructing patients to complete tasks related to everyday life of varying difficulty levels. A score of zero represents an inability to complete the task, and a score of 4 expresses the ability to complete the task independently. The total final scores range from 0 to 56. A total score of less than 45 implies balance impairment (Berg, 1989; Zwick et al., 2000).

  Change from baseline BBS at 4-week

Secondary Outcomes (1)

• Timed-Up and Go (TUG)

  Change from baseline TUG at 4-week

Study Arms (2)

Telko plus conventional physical therapy (CPT)

EXPERIMENTAL

All patients received 15-minute CPT, three times a week, for four weeks. The patients in the experimental group received 15-minute Telko at the end of each CPT session.

Combination Product: Telko plus conventional physical therapy (CPT)

Conventional physiotherapy

ACTIVE COMPARATOR

All patients received 15-minute CPT, three times a week, for four weeks.

Combination Product: Telko plus conventional physical therapy (CPT)

Interventions

Telko plus conventional physical therapy (CPT) COMBINATION_PRODUCT

All patients underwent about 15-minute CPT sessions 3 days a week for 4 weeks. The CPT intervention program consisted of closed kinetic chain exercises (squatting, hip bridge, lunge, and toe standing), 3 sets, 10 repetitions each and gait training (walking forward, backward, sidewalk, and between obstacles). Short breaks (1-5 minutes) were provided, depending on the patient tolerance. Before treatment, the skilled physical therapist was instructed about the duration, frequency, and content of therapy. The patients in the experimental group received additional lower extremities closed kinetic chain training using the Telko device. The participants train on Telko for 15 minutes using moderate resistance, 3 days a week for 4 weeks.

Also known as: conventional physiotherapy

Conventional physiotherapy; Telko plus conventional physical therapy (CPT)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Multiple Sclerosis
• Over 20 years of age
• Expanded Disability Status Scale (EDSS) score equal to or less than 5.5.

You may not qualify if:

• Neurologic or orthopaedic disorders (e.g., stroke, fractures)
• Severe cognitive impairments
• Spasticity more than 4 based on MAS.

Sponsors & Collaborators

• Anas Radi Hassan Alashram: lead

Study Sites (1)

Isra University

Amman, 11199, Jordan

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Elvira Padua, PhD

  Universita Telematica San Raffaele Roma Srl

  STUDY DIRECTOR

Central Study Contacts

ANAS R ALASHRAM, PhD

CONTACT

+962788088509; anasalashram@gmail.com

Giuseppe Annino, PhD

CONTACT

g_annino@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 15, 2022
• Study Start: July 4, 2023
• Primary Completion: August 16, 2023
• Study Completion: August 20, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)