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Multiple SclerosisNCT05460299

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

A study testing Telko plus conventional physical therapy (CPT) in people with Multiple Sclerosis, run by Anas Radi Hassan Alashram at 1 site in Jordan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Telko plus conventional physical therapy (CPT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteJordan
Study dates
4 Jul 2023to 20 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

ANAS R ALASHRAM, PhD contact

+962788088509

anasalashram@gmail.com

Giuseppe Annino, PhD contact

g_annino@hotmail.com

Jordan1 site
  • Isra University

    Amman, 11199

    Samer H Alali, +962799643494, samer.alali@iu.edu.jo

Other trials in Jordan

About this study

Official title: Effects of Closed Kinetic Chain Exercises on Balance and Gait in People With Multiple Sclerosis: A Randomized Controlled Trial

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.

Read the 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).

Being tested
Telko plus conventional physical therapy (CPT)
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telko plus conventional physical therapy (CPT)Combination product

    Also called conventional physiotherapy

    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.

Study groups in NCT05460299
Study groupRoleWhat they receive
Telko plus conventional physical therapy (CPT)ExperimentalAll 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.
Receives: Combination Product: Telko plus conventional physical therapy (CPT)
Conventional physiotherapyActive comparatorAll patients received 15-minute CPT, three times a week, for four weeks.
Receives: Combination Product: Telko plus conventional physical therapy (CPT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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).

    Measured: Change from baseline BBS at 4-week

Secondary outcomes (1)
  1. Timed-Up and Go (TUG)

    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).

    Measured: Change from baseline TUG at 4-week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2022
  2. Study start4 Jul 2023 (estimated)
  3. Primary completion16 Aug 2023 (estimated)
  4. Study completion20 Aug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05460299
Sponsor's protocol ID
SREC/22/05/043
Status last verified
Jun 2023
First submitted
12 Jul 2022
Last updated
13 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alashram AR. Effects of closed kinetic chain exercises on balance and gait in people with multiple sclerosis: A randomized controlled trial. J Bodyw Mov Ther. 2024 Oct;40:914-920. doi: 10.1016/j.jbmt.2024.06.013. Epub 2024 Jun 27.

    PubMed 39593695

Questions about this trial

What is this clinical trial studying?

A study testing Telko plus conventional physical therapy (CPT) in people with Multiple Sclerosis, run by Anas Radi Hassan Alashram at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact ANAS R ALASHRAM, PhD (+962788088509, anasalashram@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-minute walk test (6-MWT) (time frame: Change from baseline 6-minute walk test at 4-week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05460299, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.

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