NCT05639517

Brief Summary

Core stability, which is affected from the early period in with patients Multiple Sclerosis (PwMS), is due to deterioration in the somatosensory, motor and musculoskeletal systems. Based on the knowledge that core stability is effective on many functions, it is seen that trunk stabilization exercises are included in the physiotherapy and rehabilitation programs of patients. However, the effectiveness of augmented reality-based telerehabilitation application, which includes trunk stabilization training in PwMS, has not been adequately investigated in the literature. The aim of the study is to investigate the effectiveness of augmented reality-based telerehabilitation application, which includes trunk stabilization training, on neuromuscular and sensorimotor parameters in PwMS.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2023

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 6, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

February 10, 2023

Status Verified

November 1, 2022

Enrollment Period

1.7 years

First QC Date

November 26, 2022

Last Update Submit

February 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Balance

    MiniBESTest will be used to evaluate the static and dynamic balance.It consists of 14 questions including antisipatuar postural reaction, reactive postural control, sensory orientation and dynamic balance. The test is scored between 0-28 points. The highest score indicates good balance.

    Change from baseline at 8 weeks

Secondary Outcomes (8)

  • Muscle Activity

    Change from baseline at 8 weeks

  • Core Muscle Endurance-Trunk Flexor

    Change from baseline at 8 weeks

  • Core Muscle Endurance- Trunk Extansor

    Change from baseline at 8 weeks

  • Core Muscle Endurance- Side Bridge

    Change from baseline at 8 weeks

  • Trunk Position Sense

    Change from baseline at 8 weeks

  • +3 more secondary outcomes

Study Arms (2)

Group 1

EXPERIMENTAL

Patients in this group will receive spinal stabilization training through augmented reality based telerehabilitation application.

Other: Augmented Reality Based Telerehabilitation Application

Group 2

ACTIVE COMPARATOR

Patients in this group will receive spinal stabilization training face-to-face.

Other: Training face-to-face

Interventions

Spinal stabilization training with augmented reality-based telerehabilitation will be applied twice a week for 8 weeks.

Group 1

Spinal stabilization training will be applied face-to-face twice a week for 8 weeks.

Group 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with relapsing remitting MS by a neurologist,
  • Having a disability level between 1 and 5 according to the Expanded Disability Status Scale (EDSS),
  • Those who get over 24 points in the Standardized Mini Mental State Test (SMMT),
  • Those who have not had an MS attack in the last three months,
  • Volunteer individuals

You may not qualify if:

  • Receiving corticosteroid therapy in the last 4 weeks,
  • Having additional neurological disease that may cause balance disorder
  • Individuals who have had surgery related to the spine, hip, knee or ankle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2022

First Posted

December 6, 2022

Study Start

January 30, 2023

Primary Completion

September 30, 2024

Study Completion

December 15, 2024

Last Updated

February 10, 2023

Record last verified: 2022-11