NCT06001424

Brief 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. Aim of Study: to investigate the effect of life kinetik training on lower limb coordination in MS patients with ataxia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 24, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2021

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

2.9 years

First QC Date

January 17, 2021

Last Update Submit

August 18, 2023

Conditions

Keywords

Multiple Sclerosisataxiacoordinationlife kinetic exercises

Outcome Measures

Primary Outcomes (2)

  • Lower Extremity Motor Coordination Test (LEMOCOT)

    test to assess lower limb coordination

    at baseline

  • Lower Extremity Motor Coordination Test (LEMOCOT)

    test to assess lower limb coordination

    post intervention (after one month)

Secondary Outcomes (2)

  • Four Square Step Test (FSST)

    at baseline

  • Four Square Step Test (FSST)

    post intervention (after one month)

Study Arms (2)

study group

EXPERIMENTAL

will receive physical therapy program of in addition to life kinetik training.

Other: physical therapyOther: life kinetic exercises

control

ACTIVE COMPARATOR

will receive physical therapy program

Other: physical therapy

Interventions

Frenkel's exercises for lower limb, Proprioceptive neuromuscular facilitation for upper limb in the form of rhythmic stabilization

controlstudy group

A multimodal training that combines coordinative, cognitive and visual tasks.

study group

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • MS from both sexes
  • Patients' age will be ranged from 20 to 45 years
  • Expanded disability scale (EDSS) score ranging from "two" to "four"

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Giza, 11432, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 34931569BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisAtaxia

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Moshera H Darwish, Prf. Dr

    Professor of Physical therapy for Neurology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trail
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof. Dr. of Physical therapy for Neurology

Study Record Dates

First Submitted

January 17, 2021

First Posted

August 21, 2023

Study Start

June 24, 2018

Primary Completion

April 30, 2021

Study Completion

May 29, 2021

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations