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

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.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Procedure: perturbation training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Isparta, Turkey
    • Hatice Yakut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dynamic balance	the effects of perturbation dynamic balance training assessed with four square step test >15 seconds = increased risk of falls	6 week
walking	the effects of perturbation dynamic balance training assessed with 10 meter walking test	6 week
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	6 week
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.	6 week
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	6 week

Collaborators and Investigators

• Sponsor: Suleyman Demirel University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2018
• Primary Completion (Anticipated): October 20, 2019
• Study Completion (Anticipated): December 20, 2019

Study Registration Dates

• First Submitted: November 23, 2017
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): October 25, 2019
• Last Update Submitted That Met QC Criteria: October 23, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Rehabilitation; Multiple sclerosis; Tailored interventions
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 12345 (Danish Center for Healthcare Improvements)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No