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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04132167
Recruitment Status : Active, not recruiting
First Posted : October 18, 2019
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
HATİCE YAKUT, Suleyman Demirel University

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Procedure: perturbation training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Supervised Perturbation Training Results in Changes in Balance and Falling in Patients With Multiple Sclerosis
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : October 20, 2019
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: training group
perturbation balance training
Procedure: perturbation training
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;

Active Comparator: control group
traditional physical therapy that including strengthening and stretching
Procedure: perturbation training
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 Measures :
  1. dynamic balance [ Time Frame: 6 week ]
    the effects of perturbation dynamic balance training assessed with four square step test >15 seconds = increased risk of falls

  2. walking [ Time Frame: 6 week ]
    the effects of perturbation dynamic balance training assessed with 10 meter walking test

  3. walking [ Time Frame: 6 week ]
    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

  4. falling [ Time Frame: 6 week ]
    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.

  5. fear of falling [ Time Frame: 6 week ]
    The short FES-I is a 7-item self-report questionnaire for measuring perceived self-efficacy to avoid a fall in various situations



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132167


Locations
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Turkey
Hatice Yakut
Isparta, Turkey
Sponsors and Collaborators
Suleyman Demirel University

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Responsible Party: HATİCE YAKUT, Principal investigator, Suleyman Demirel University
ClinicalTrials.gov Identifier: NCT04132167    
Other Study ID Numbers: 12345
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HATİCE YAKUT, Suleyman Demirel University:
Rehabilitation
Multiple sclerosis
Tailored interventions
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases