Multiple SclerosisNCT06001424
Effect of Life Kinetik Training on Lower Limb Coordination in Ataxic Patients
A study testing physical therapy and life kinetic exercises in people with Multiple Sclerosis and Ataxia, run by Cairo University at 1 site in Egypt.
Trial summary
Coordination is essential for the performance of most daily motor activities. Coordination problems are common in MS patients. One of the most commonly reported symptoms is dysmetria (limb ataxia). Ataxia is thought to occur in about 80% of MS patients. It leads to limitations in daily life activities. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Multiple Sclerosis, Ataxia
- What is being tested?
- physical therapy and life kinetic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jun 2018to 29 May 2021
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- MS from both sexes
- Patients' age will be ranged from 20 to 45 years
- Expanded disability scale (EDSS) score ranging from "two" to "four"
Who cannot join
- Patients with Ataxia caused by other cause rather than MS
- Patients with other neurological disease or orthopedic deformities may affect movement
- Patients with cardiovascular and pulmonary diseases that make exercise unsafe
- Patients with cognitive impairment or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Coordination is essential for the performance of most daily motor activities. Coordination problems are common in MS patients. One of the most commonly reported symptoms is dysmetria (limb ataxia). Ataxia is thought to occur in about 80% of MS patients. It leads to limitations in daily life activities. Aim of Study: to investigate the effect of life kinetik training on lower limb coordination in MS patients with ataxia.
Read the detailed description
Methods: Thirty remitting relapsing Multiple Sclerosis (RRMS) patients from both sexes with ataxic symptoms, will be recruited from multiple sclerosis specialized clinic in the Neurology department, Faculty of Medicine, Cairo University with EDSS score will be ranged from 2 to 4 and SARA score will be ranged from 1 to 10. Lower Extremity Motor Coordination Test (LEMOCOT) will be used to assess lower limb motor coordination. They will be randomly assigned into two equal groups; control group (GI) will receive selected physical therapy program and study group (GII) will receive same program of (GI) in addition to life kinetik training.
- Conditions
- Multiple Sclerosis, Ataxia
- Being tested
- physical therapy, life kinetic exercises
- Keywords
- Multiple Sclerosis, ataxia, coordination, life kinetic exercises
- Medical subject headings
- Multiple Sclerosis, Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapyOther
Frenkel's exercises for lower limb, Proprioceptive neuromuscular facilitation for upper limb in the form of rhythmic stabilization
life kinetic exercisesOther
A multimodal training that combines coordinative, cognitive and visual tasks.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | will receive physical therapy program of in addition to life kinetik training. Receives: Other: physical therapy; Other: life kinetic exercises |
| control | Active comparator | will receive physical therapy program Receives: Other: physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Motor Coordination Test (LEMOCOT)
test to assess lower limb coordination
Measured: at baseline
Lower Extremity Motor Coordination Test (LEMOCOT)
test to assess lower limb coordination
Measured: post intervention (after one month)
Secondary outcomes (2)
Four Square Step Test (FSST)
test to assess dynamic balance
Measured: at baseline
Four Square Step Test (FSST)
test to assess dynamic balance
Measured: post intervention (after one month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start24 Jun 2018
- Primary completion30 Apr 2021
- Study completion29 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- randomized controlled trail
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heba ahmed khalifa, Cairo University
- Investigators
- Moshera H Darwish, Prf. Dr, Study director, Professor of Physical therapy for Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001424
- Sponsor's protocol ID
- P.T.REC/012/001987
- Status last verified
- Aug 2023
- First submitted
- 17 Jan 2021
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edwards EM, Fritz NE, Therrien AS. Cerebellar Dysfunction in Multiple Sclerosis: Considerations for Research and Rehabilitation Therapy. Neurorehabil Neural Repair. 2022 Feb;36(2):103-106. doi: 10.1177/15459683211065442. Epub 2021 Dec 21.
PubMed 34931569
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Life Kinetik Training on Lower Limb Coordination in Ataxic Patients
- ClinicalTrials.gov ID
- NCT06001424
- Acronym / sponsor ID
- P.T.REC/012/001987
- Conditions
- Multiple Sclerosis, Ataxia
- Keywords
- Multiple Sclerosis, ataxia, coordination, life kinetic exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 24 Jun 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 29 May 2021 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coordination is essential for the performance of most daily motor activities. Coordination problems are common in MS patients. One of the most commonly reported symptoms is dysmetria (limb ataxia). Ataxia is thought to occur in about 80% of MS patients. It leads to limitations in daily life activities. Aim of Study: to investigate the effect of life kinetik training on lower limb coordination in MS patients with ataxia.
Detailed description
Methods: Thirty remitting relapsing Multiple Sclerosis (RRMS) patients from both sexes with ataxic symptoms, will be recruited from multiple sclerosis specialized clinic in the Neurology department, Faculty of Medicine, Cairo University with EDSS score will be ranged from 2 to 4 and SARA score will be ranged from 1 to 10. Lower Extremity Motor Coordination Test (LEMOCOT) will be used to assess lower limb motor coordination. They will be randomly assigned into two equal groups; control group (GI) will receive selected physical therapy program and study group (GII) will receive same program of (GI) in addition to life kinetik training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trail
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: physical therapy, Other: life kinetic exerciseswill receive physical therapy program of in addition to life kinetik training. |
| control | Active comparator | Other: physical therapywill receive physical therapy program |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- MS from both sexes
- Patients' age will be ranged from 20 to 45 years
- Expanded disability scale (EDSS) score ranging from "two" to "four"
Key exclusion criteria (4 listed)
- Patients with Ataxia caused by other cause rather than MS
- Patients with other neurological disease or orthopedic deformities may affect movement
- Patients with cardiovascular and pulmonary diseases that make exercise unsafe
- Patients with cognitive impairment or psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical therapyFrenkel's exercises for lower limb, Proprioceptive neuromuscular facilitation for upper limb in the form of rhythmic stabilization | Other | control, study group |
| life kinetic exercisesA multimodal training that combines coordinative, cognitive and visual tasks. | Other | study group |
Primary outcome
Lower Extremity Motor Coordination Test (LEMOCOT)
Time frame: at baseline
test to assess lower limb coordination
Lower Extremity Motor Coordination Test (LEMOCOT)
Time frame: post intervention (after one month)
test to assess lower limb coordination
2 secondary outcomes
Four Square Step Test (FSST)
Time frame: at baseline
Four Square Step Test (FSST)
Time frame: post intervention (after one month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Background: PubMed 34931569Edwards EM, Fritz NE, Therrien AS. Cerebellar Dysfunction in Multiple Sclerosis: Considerations for Research and Rehabilitation Therapy. Neurorehabil Neural Repair. 2022 Feb;36(2):103-106. doi: 10.1177/15459683211065442. Epub 2021 Dec 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moshera H Darwish, Prf. Dr study director
Professor of Physical therapy for Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy and life kinetic exercises in people with Multiple Sclerosis and Ataxia, run by Cairo University at 1 site in Egypt.
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 4 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: finished, as of the sponsor's last update on 21 Aug 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Extremity Motor Coordination Test (LEMOCOT) (time frame: at baseline). 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 NCT06001424, 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 21 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.