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Supervised Perturbation Training Results in Changes in Balance and Falling in Patients With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
perturbation training
Sponsored by
Suleyman Demirel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Rehabilitation, Multiple sclerosis, Tailored interventions

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • An age older than 18 years
  • Stable phase of the disease without relapses or worsening in the last three months
  • Referring fear of falling or a history of falls (at least one fall in the last year).
  • Individuals with a high level of balance.

Exclusion Criteria:

  • Psychiatric disorders
  • Blurred vision
  • Severe cognitive impairment
  • Severely impaired upright postural control or limited participation in a rehabilitation program
  • Cardiovascular and respiratory disorders.

Sites / Locations

  • Hatice Yakut

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

training group

control group

Arm Description

perturbation balance training

traditional physical therapy that including strengthening and stretching

Outcomes

Primary Outcome Measures

dynamic balance
the effects of perturbation dynamic balance training assessed with four square step test >15 seconds = increased risk of falls
walking
the effects of perturbation dynamic balance training assessed with 10 meter walking test
walking
the effects of perturbation dynamic balance training assessed with time up and go test(TUG).A score of 30 seconds or more suggests that the person may be prone to falls
falling
the effects of perturbation dynamic balance training assessed with Falling Efficacy Scale(FES). The FES is a 10-item test. On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all.
fear of falling
The short FES-I is a 7-item self-report questionnaire for measuring perceived self-efficacy to avoid a fall in various situations

Secondary Outcome Measures

Full Information

First Posted
November 23, 2017
Last Updated
October 23, 2019
Sponsor
Suleyman Demirel University
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1. Study Identification

Unique Protocol Identification Number
NCT04132167
Brief Title
Supervised Perturbation Training Results in Changes in Balance and Falling in Patients With Multiple Sclerosis
Official Title
Supervised Perturbation Training Results in Changes in Balance and Falling in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
October 20, 2019 (Anticipated)
Study Completion Date
December 20, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suleyman Demirel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Physical exercise can prevent falls, certain types of exercise may be more effective. Perturbation-based balance training is a novel intervention involving repeated postural perturbations aiming to improve control of rapid balance reactions. The purpose of this study was to estimate the effect of perturbation- based balance training on falls and balance in daily life.Thirty patients with multiple sclerosis (PwMS) will assess with regard to dynamic balance, walking and falling. Patients randomly will allocate to a personalized (PRG) or traditional (TRG) rehabilitation group.
Detailed Description
Thirty patients with multiple sclerosis (PwMS) will assess with regard to dynamic balance, walking and falling. Patients randomly will allocate to a personalized (PRG) or traditional (TRG) rehabilitation group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Rehabilitation, Multiple sclerosis, Tailored interventions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
training group
Arm Type
Experimental
Arm Description
perturbation balance training
Arm Title
control group
Arm Type
Active Comparator
Arm Description
traditional physical therapy that including strengthening and stretching
Intervention Type
Procedure
Intervention Name(s)
perturbation training
Intervention Description
exercises for body stability in different positions (bridge, sitting, quadrupedal, half- kneeling, kneeling, standing, monopodalic) performed with visual biofeedback; transfers training performed in front of a mirror; ambulation training with courses drawn on the ground in a straight line and with more complex tracks with visual controlin particular using the protocols seated balance/strength training, standing bal- ance/weight-bearing training, mobility training and closed-chain training;
Primary Outcome Measure Information:
Title
dynamic balance
Description
the effects of perturbation dynamic balance training assessed with four square step test >15 seconds = increased risk of falls
Time Frame
6 week
Title
walking
Description
the effects of perturbation dynamic balance training assessed with 10 meter walking test
Time Frame
6 week
Title
walking
Description
the effects of perturbation dynamic balance training assessed with time up and go test(TUG).A score of 30 seconds or more suggests that the person may be prone to falls
Time Frame
6 week
Title
falling
Description
the effects of perturbation dynamic balance training assessed with Falling Efficacy Scale(FES). The FES is a 10-item test. On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all.
Time Frame
6 week
Title
fear of falling
Description
The short FES-I is a 7-item self-report questionnaire for measuring perceived self-efficacy to avoid a fall in various situations
Time Frame
6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: An age older than 18 years Stable phase of the disease without relapses or worsening in the last three months Referring fear of falling or a history of falls (at least one fall in the last year). Individuals with a high level of balance. Exclusion Criteria: Psychiatric disorders Blurred vision Severe cognitive impairment Severely impaired upright postural control or limited participation in a rehabilitation program Cardiovascular and respiratory disorders.
Facility Information:
Facility Name
Hatice Yakut
City
Isparta
Country
Turkey

12. IPD Sharing Statement

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Supervised Perturbation Training Results in Changes in Balance and Falling in Patients With Multiple Sclerosis

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