Bicycle Ergometer Training in Duchenne Muscular Dystrophy

Duchenne Muscular Dystrophy Clinical Trial

— BETDMD  

Official title:

The Effects of Bicycle Training on Gait and Balance in Children With Duchenne Muscular Dystrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05330195
• Other study ID #: 2022008
• Status: Completed
• Phase: N/A
• Start date: April 18, 2022
• Est. completion date: May 25, 2023

Study information

• Verified date: October 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 25, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Duchenne Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne

Intervention

Other:
• Bicycle Ergometer Training
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.
• 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 these for 3 to 5 days a week.

Locations

Country	Name	City	State
Turkey	Hacettepe University, Faculty of Physical Therapy and Rehabilitation	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 minutes
Primary	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.	5 minutes
Primary	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 %.	5 minutes
Primary	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.	5 minutes
Primary	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.	5 minutes
Primary	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).	10 minutes
Primary	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).	10 minutes