NCT05635890

Brief Summary

The Cawthorne Cooksey exercises and conventional program of physical therapy were administered.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

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

May 6, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
Last Updated

December 2, 2022

Status Verified

November 1, 2022

Enrollment Period

3 months

First QC Date

November 13, 2022

Last Update Submit

November 22, 2022

Conditions

Vestibular Rehabilitation in MS

Keywords

Trunk kinetic and kinematic parameters, Vestibular rehabilitation, Multiple Sclerosis.

Outcome Measures

Primary Outcomes (3)

  • Isokinetic dynamometer (average power)

    Assess trunk kinetic and kinematic parameters.

    4 weeks

  • Isokinetic dynamometer (acceleration time)

    Assess trunk kinetic and kinematic parameters.

    4 weeks

  • Isokinetic dynamometer (deceleration time)

    Assess trunk kinetic and kinematic parameters.

    4 weeks

Study Arms (2)

Group I

EXPERIMENTAL

received conventional vestibular rehabilitation along with the Cawthorne Cooksey exercise protocol

Other: Cawthorne Cooksey exercise protocolOther: conventional vestibular rehabilitation

Group II

ACTIVE COMPARATOR

received conventional vestibular rehabilitation only

Other: conventional vestibular rehabilitation

Interventions

Cawthorne Cooksey exercise protocolOTHER

Cawthorne Cooksey exercise protocol

Group I
conventional vestibular rehabilitationOTHER

conventional vestibular rehabilitation

Group IGroup II

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 35-55 years.
  • Ambulatory without assistance.
  • Diagnosed with relapsing-remitting MS by a neurologist, with approximately five relapse attacks in the hemiparesis type with a muscular tone of 1 or 1+ depending on the MAS, or modified Ashworth scale.
  • All individuals were evaluated by a neurosurgeon to confirm central vertigo using test of Dix Hallpike.
  • Degree of MS-related disability based on the enlarged disability status scale, ranging from 2-2.5.

You may not qualify if:

  • People with musculoskeletal deformities.
  • People with inner ear abnormalities.
  • People with psychiatric disturbances or seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 University

El-Sheikh Zayed City, Giza Governorate, 1133, Egypt

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical Therapy at department of neurology

Study Record Dates

First Submitted

November 13, 2022

First Posted

December 2, 2022

Study Start

May 6, 2022

Primary Completion

August 10, 2022

Study Completion

September 20, 2022

Last Updated

December 2, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)