- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05460299
Closed Kinetic Chain Exercises for Balance and Gait Rehabilitation for People With MS
Effects of Closed Kinetic Chain Exercises on Balance and Gait in People With Multiple Sclerosis: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants were included in the present study with a confirmed diagnosis of MS, adults over 20 years of age, and the Expanded Disability Status Scale (EDSS) score equal to or less than 5.5. Exclusion criteria were having any neurologic or orthopaedic disorders that influenced the patients' motor function (e.g., stroke, fractures), severe cognitive impairments, and spasticity more than 4 based on MAS.
The patients were randomly allocated to either the lower extremities closed kinetic chain training (Telko) and conventional physiotherapy (CPT) experimental group or the CPT alone control group. Permuted block randomisation was used with a block size of 4, and treatment assignment was concealed using sealed envelopes. The randomisation sequence was generated using the statistical analysis software, MedCalc version.
Conventional physiotherapy (CPT) 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.
Lower extremities closed kinetic chain training 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.
Outcome measures The participants in both groups were clinically assessed at the baseline, the end of week 4 of treatment, and the 4-week follow-up by one assessor blinded to the intervention. Demographic information from each participant, including age, sex, body mass index (BMI), family history of MS, and the EDSS scores, was collected. The participants were assessed using the 6-minute walk test (6-MWT), Berg Balance Scale (BBS), and Timed-Up and Go (TUG).
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. Gait speed was exhibited in meters per minute by dividing the total distance covered in the 6-MWT by 6 minutes.
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 the 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).
The TUG is a simple test used to evaluate an individual's mobility and demands static and dynamic balance (Kear et al., 2017). It has excellent reliability (ICC = 0.98) in people with MS (Valet et al., 2019). It utilises the time that an individual takes to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally need. Scores of 10 seconds or less exhibit normal mobility, 11 - 20 seconds are within normal limits for disabled individuals, and greater than 20 seconds implies the individual needs aid outside and suggests additional examination and intervention (Kear et al., 2017). A score of 30 seconds or more points that the individual may be prone to falls (José Gonçalves et al., 2015).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ANAS R ALASHRAM, PhD
- Phone Number: +962788088509
- Email: anasalashram@gmail.com
Study Contact Backup
- Name: Giuseppe Annino, PhD
- Email: g_annino@hotmail.com
Study Locations
-
-
-
Amman, Jordan, 11199
- Isra University
-
Contact:
- Samer H Alali
- Phone Number: +962799643494
- Email: samer.alali@iu.edu.jo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Multiple Sclerosis
- Over 20 years of age
- Expanded Disability Status Scale (EDSS) score equal to or less than 5.5.
Exclusion Criteria:
- Neurologic or orthopaedic disorders (e.g., stroke, fractures)
- Severe cognitive impairments
- Spasticity more than 4 based on MAS.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telko plus conventional physical therapy (CPT)
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.
|
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.
Other Names:
|
Active Comparator: Conventional physiotherapy
All patients received 15-minute CPT, three times a week, for four weeks.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6-minute walk test (6-MWT)
Time Frame: Change from baseline 6-minute walk test at 4-week
|
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)
Time Frame: Change from baseline BBS at 4-week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed-Up and Go (TUG)
Time Frame: Change from baseline TUG at 4-week
|
The TUG is a simple test used to evaluate an individual's mobility and demands static and dynamic balance (Kear et al., 2017).
It has excellent reliability (ICC = 0.98) in people with MS (Valet et al., 2019).
It utilises the time that an individual takes to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down.
During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally need.
Scores of 10 seconds or less exhibit normal mobility, 11 - 20 seconds are within normal limits for disabled individuals, and greater than 20 seconds implies the individual needs aid outside and suggests additional examination and intervention (Kear et al., 2017).
A score of 30 seconds or more points that the individual may be prone to falls (José Gonçalves et al., 2015).
|
Change from baseline TUG at 4-week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Elvira Padua, PhD, Universita Telematica San Raffaele Roma Srl
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SREC/22/05/043
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Sclerosis
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsRecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
University of California, San FranciscoUnited States Department of DefenseRecruitingMultiple Sclerosis, Chronic Progressive | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis (MS) | Multiple Sclerosis Relapse | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis Brain Lesion | Multiple Sclerosis BenignUnited States
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Banc de Sang i TeixitsVall d'Hebron Research Institute (VHIR)CompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisSpain
-
BiogenElan PharmaceuticalsCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Queen Mary University of LondonTakeda Pharmaceuticals International, Inc.RecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited Kingdom
Clinical Trials on Telko plus conventional physical therapy (CPT)
-
Federal University of BahiaFundação de Amparo à Pesquisa do Estado da BahiaUnknown
-
University of LahoreCompletedLow Back Pain, MechanicalPakistan
-
Kars State HospitalCompletedShoulder Pain | Myofascial Pain | HemiplegiaTurkey
-
Kırıkkale UniversityCompletedStroke PatientsTurkey
-
St George's, University of LondonThe Health FoundationCompleted
-
Cairo UniversityRecruiting
-
St George's, University of LondonCompleted
-
Riphah International UniversityCompletedAdhesive Capsulitis of ShoulderPakistan
-
Naval Health Research CenterUnited States Naval Medical Center, San Diego; Walter Reed National Military... and other collaboratorsRecruitingDysfunction of Vestibular System | MTBI - Mild Traumatic Brain InjuryUnited States
-
Riphah International UniversityCompleted