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Bicycle Ergometer Training in Duchenne Muscular Dystrophy (BETDMD)

Primary Purpose

Duchenne Muscular Dystrophy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bicycle Ergometer Training
Home-based exercise group
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Duchenne Muscular Dystrophy focused on measuring Duchenne muscular dystrophy, Bicycle training, Gait, Balance

Eligibility Criteria

5 Years - 12 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Children have diagnosis of DMD confirmed by genetic analysis,
  • Children can walk with unsupported.

Exclusion criteria:

  • Children have undergone any surgery or suffered injury of the lower limbs,
  • Children have severe contractures of lower limbs,
  • Children have low cooperation
  • Children have comorbid disease,
  • Children were applied regular aerobic training such as bicycle training and hydrotherapy in last 6 months.

Sites / Locations

  • Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Group

Control Group

Arm Description

Home exercise program Children will be given a home program including stretching, breathing, normal joint movement, body weight and mildly resistant exercises, and children will be asked to do these for 3 to 5 days a week. Also, aerobic training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 40 minutes total duration consisting of 5 min warm up and 5 min cool down period to children in treatment group

Home Based Exercise Group Children will be given a home program including stretching, breathing, normal joint movement, body weight and mildly resistant exercises, and children will be asked to do this program for 3-5 days a week.

Outcomes

Primary Outcome Measures

Step Time and Cycle Time(Gait)
The gait of patients with DMD was assessed by GAITrite (CIR Systems Inc., Franklin, New Jersey, USA) electronic walkway system, objective assessment of spatio-temporal characteristics of gait, at a self-selected speed for 3 times. With this walkway system, ambulation time (s) was evaluated.
Step Length, Stride Length and base of support (Gait)
The gait of patients with DMD was assessed by GAITrite (CIR Systems Inc., Franklin, New Jersey, USA) electronic walkway system, objective assessment of spatio-temporal characteristics of gait, at a self-selected speed for 3 times. With this walkway system,step length (cm), stride length (cm) and base of support (cm) were evaluated.
Single support, double support, swing phase and stance phase (Gait)
The gait of patients with DMD was assessed by GAITrite (CIR Systems Inc., Franklin, New Jersey, USA) electronic walkway system, objective assessment of spatio-temporal characteristics of gait, at a self-selected speed for 3 times. With this walkway system, single support, double support, swing phase and stance phase were stated as %.
Velocity (Gait)
The gait of patients with DMD was assessed by GAITrite (CIR Systems Inc., Franklin, New Jersey, USA) electronic walkway system, objective assessment of spatio-temporal characteristics of gait, at a self-selected speed for 3 times. With this walkway system, Velocity (cm/s) was evaluated.
Cadence (Gait)
The gait of patients with DMD was assessed by GAITrite (CIR Systems Inc., Franklin, New Jersey, USA) electronic walkway system, objective assessment of spatio-temporal characteristics of gait, at a self-selected speed for 3 times. With this walkway system, cadence (steps/min) was recorded.
Balance (rigid surface)
The balance plate system used to assess balance and degree of postural sway was the Bertec Balance Check Screener™ (BP5050 Bertec Co., Columbus, OH, USA). The system consists of a 20 × 20-inch platform at ground level connected to a computer. Postural sway, which measures the displacement of the center of gravity, was assessed on rigid surface, in 2 conditions (eyes opened-closed) and 2 directions (anteroposterior and mediolateral).
Balance (perturbated surface)
The balance plate system used to assess balance and degree of postural sway was the Bertec Balance Check Screener™ (BP5050 Bertec Co., Columbus, OH, USA). The system consists of a 20 × 20-inch platform at ground level connected to a computer. Postural sway, which measures the displacement of the center of gravity, was assessed on perturbated surface, in 2 conditions (eyes opened-closed) and 2 directions (anteroposterior and mediolateral).

Secondary Outcome Measures

Full Information

First Posted
March 31, 2022
Last Updated
October 10, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05330195
Brief Title
Bicycle Ergometer Training in Duchenne Muscular Dystrophy
Acronym
BETDMD
Official Title
The Effects of Bicycle Training on Gait and Balance in Children With Duchenne Muscular Dystrophy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 18, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
May 25, 2023 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The progressive muscle weakness and contractures of the patients adversely affect their gait and balance. It is known that the disorder of the patients' balance and gait affects their functional capacity. The aim of this study is to examine the effects of bicycle ergometer training on gait and balance in children with Duchenne Muscular Dystrophy. Twenty-four children with DMD included in the study will be divided into two groups as home program and home program+bicycle ergometer training with block randomization method. Home program including stretching, respiratory, range of motion, posture and mild resistance exercise with body weight will be asked to apply 3-5 days a week for 12 weeks, aerobic training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 40 minutes total duration consisting of 5 min warm up and 5 min cool down period. Gait and balance were evaluated with GAITrite and Bertec Balance Check Screener, successively. Assessments will be applied at pre-training and after 12 weeks of training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duchenne Muscular Dystrophy
Keywords
Duchenne muscular dystrophy, Bicycle training, Gait, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Block Randomized controlled study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Home exercise program Children will be given a home program including stretching, breathing, normal joint movement, body weight and mildly resistant exercises, and children will be asked to do these for 3 to 5 days a week. Also, aerobic training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 40 minutes total duration consisting of 5 min warm up and 5 min cool down period to children in treatment group
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Home Based Exercise Group Children will be given a home program including stretching, breathing, normal joint movement, body weight and mildly resistant exercises, and children will be asked to do this program for 3-5 days a week.
Intervention Type
Other
Intervention Name(s)
Bicycle Ergometer Training
Intervention Description
Bicycle ergometer training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 40 minutes total duration consisting of 5 min warm up and 5 min cool down period to children in treatment group.
Intervention Type
Other
Intervention Name(s)
Home-based exercise group
Intervention Description
Children will be given a home program including stretching, breathing, normal joint movement, body weight and mildly resistant exercises, and children will be asked to do these for 3 to 5 days a week.
Primary Outcome Measure Information:
Title
Step Time and Cycle Time(Gait)
Description
The gait of patients with DMD was assessed by GAITrite (CIR Systems Inc., Franklin, New Jersey, USA) electronic walkway system, objective assessment of spatio-temporal characteristics of gait, at a self-selected speed for 3 times. With this walkway system, ambulation time (s) was evaluated.
Time Frame
5 minutes
Title
Step Length, Stride Length and base of support (Gait)
Description
The gait of patients with DMD was assessed by GAITrite (CIR Systems Inc., Franklin, New Jersey, USA) electronic walkway system, objective assessment of spatio-temporal characteristics of gait, at a self-selected speed for 3 times. With this walkway system,step length (cm), stride length (cm) and base of support (cm) were evaluated.
Time Frame
5 minutes
Title
Single support, double support, swing phase and stance phase (Gait)
Description
The gait of patients with DMD was assessed by GAITrite (CIR Systems Inc., Franklin, New Jersey, USA) electronic walkway system, objective assessment of spatio-temporal characteristics of gait, at a self-selected speed for 3 times. With this walkway system, single support, double support, swing phase and stance phase were stated as %.
Time Frame
5 minutes
Title
Velocity (Gait)
Description
The gait of patients with DMD was assessed by GAITrite (CIR Systems Inc., Franklin, New Jersey, USA) electronic walkway system, objective assessment of spatio-temporal characteristics of gait, at a self-selected speed for 3 times. With this walkway system, Velocity (cm/s) was evaluated.
Time Frame
5 minutes
Title
Cadence (Gait)
Description
The gait of patients with DMD was assessed by GAITrite (CIR Systems Inc., Franklin, New Jersey, USA) electronic walkway system, objective assessment of spatio-temporal characteristics of gait, at a self-selected speed for 3 times. With this walkway system, cadence (steps/min) was recorded.
Time Frame
5 minutes
Title
Balance (rigid surface)
Description
The balance plate system used to assess balance and degree of postural sway was the Bertec Balance Check Screener™ (BP5050 Bertec Co., Columbus, OH, USA). The system consists of a 20 × 20-inch platform at ground level connected to a computer. Postural sway, which measures the displacement of the center of gravity, was assessed on rigid surface, in 2 conditions (eyes opened-closed) and 2 directions (anteroposterior and mediolateral).
Time Frame
10 minutes
Title
Balance (perturbated surface)
Description
The balance plate system used to assess balance and degree of postural sway was the Bertec Balance Check Screener™ (BP5050 Bertec Co., Columbus, OH, USA). The system consists of a 20 × 20-inch platform at ground level connected to a computer. Postural sway, which measures the displacement of the center of gravity, was assessed on perturbated surface, in 2 conditions (eyes opened-closed) and 2 directions (anteroposterior and mediolateral).
Time Frame
10 minutes

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Because DMD is X linked recessive disorder, this disorder is seen in male.
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children have diagnosis of DMD confirmed by genetic analysis, Children can walk with unsupported. Exclusion criteria: Children have undergone any surgery or suffered injury of the lower limbs, Children have severe contractures of lower limbs, Children have low cooperation Children have comorbid disease, Children were applied regular aerobic training such as bicycle training and hydrotherapy in last 6 months.
Facility Information:
Facility Name
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
City
Ankara
State/Province
Altındağ
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Bicycle Ergometer Training in Duchenne Muscular Dystrophy

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