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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04132167
Other study ID # 12345
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 20, 2018
Est. completion date December 20, 2019

Study information

Verified date October 2019
Source Suleyman Demirel University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 15
Est. completion date December 20, 2019
Est. primary completion date October 20, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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;

Locations

Country Name City State
Turkey Hatice Yakut Isparta

Sponsors (1)

Lead Sponsor Collaborator
Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary dynamic balance the effects of perturbation dynamic balance training assessed with four square step test >15 seconds = increased risk of falls 6 week
Primary walking the effects of perturbation dynamic balance training assessed with 10 meter walking test 6 week
Primary 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
Primary 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
Primary 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
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