NCT04132167

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.

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
15

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Nov 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2017

Completed
12 months until next milestone

Study Start

First participant enrolled

November 20, 2018

Completed
11 months until next milestone

First Posted

Study publicly available on registry

October 18, 2019

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

November 23, 2017

Last Update Submit

October 23, 2019

Conditions

Multiple Sclerosis

Keywords

RehabilitationMultiple sclerosisTailored interventions

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

training group

EXPERIMENTAL

perturbation balance training

Procedure: perturbation training

control group

ACTIVE COMPARATOR

traditional physical therapy that including strengthening and stretching

Procedure: perturbation training

Interventions

perturbation trainingPROCEDURE

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;

control grouptraining group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatice Yakut

Isparta, Turkey (Türkiye)

Location

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
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 23, 2017

First Posted

October 18, 2019

Study Start

November 20, 2018

Primary Completion

October 20, 2019

Study Completion

December 20, 2019

Last Updated

October 25, 2019

Record last verified: 2019-10

Locations

TU(1)