NCT03718819

Brief Summary

Multiple sclerosis is a progressive neurological disease that associated with demyelinization and axonal damage. Decreased postural control is one of the initial symptom of disease. Improving postural control in people with neurological impairment is a common goal of physiotherapy. Doing exercises in water or land are examples for effective solutions. Pilates and aquaplyometric exercises are some of these approaches. Performing daily activities at the same time requires dual tasking or multi tasking. Dual tasking is frequently impaired in MS. The aim of the study was to determine effect of combined Pilates and Aquaplyometric exercises on postural control with or without dual task in patients with multiple sclerosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

9 months

First QC Date

October 16, 2018

Last Update Submit

October 25, 2018

Conditions

Multiple Sclerosis

Keywords

multiple sclerosispilatesaquatherapypostural controldual task

Outcome Measures

Primary Outcomes (2)

  • Change in limits of stability parameter with Biodex Balance System

    measured with Biodex Balance System (BBS; SD 12.1"Display 115 VAC). Patients were asked to stand on the rigid surface with barefoot and eyes open during measuring limits of stability. During each test trial, patients must shift their weight to move the cursor from the center target to a blinking target and back as quickly and with as little deviation as possible. The same process is repeated for each of the nine targets. Targets on the screen blink in random order. The tests repeated three times with 30 second resting time between trials. Patients' performance is evaluated from a total score of 100 where the higher score represents better trunk control.

    Baseline and 8 weeks

  • Change in limits of stability parameter with cognitive task by Biodex Balance System

    Patients are asked to perform previously explained test protocol while maintaining balance they need to count down three-by-three from a randomly selected two-digit number. . Patients' performance is evaluated from a total score of 100 where the higher score represents better trunk control.

    Baseline and 8 weeks

Secondary Outcomes (5)

  • Change in Nine hole peg Test

    Baseline and 8 weeks

  • Change in timed up and go test

    Baseline and 8 weeks

  • Change in 5-Repetititon Sit-To-Stand Test

    Baseline and 8 weeks

  • Change in timed 25 step walking test

    Baseline and 8 weeks

  • Handgrip strength test

    Baseline and 8 weeks

Interventions

exerciseOTHER

Pilates and aquaplyometric exercises will be done combinedly.

Eligibility Criteria

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

You may qualify if:

  • being over 18 years old
  • ability to walk independently or with single walking aid
  • having stable symptoms

You may not qualify if:

  • being acute or unstable phase of disease
  • having EDSS score\>6
  • insuitable for the pool (incontinance, dermatological disease etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylül University, School of Physical Therapy and Rehabilitation

Izmir, Balçova, 35330, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Barış Gürpınar, PhD

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melda Soysal Tomruk, PhD

CONTACT

+905376053045melda.soysal@deu.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 16, 2018

First Posted

October 24, 2018

Study Start

March 1, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

October 29, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

via clinical study

Shared Documents
CSR
Time Frame
in 2 years

Locations

TU(1)