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Bicycle Ergometer Training in Duchenne Muscular Dystrophy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05330195
Acronym
BETDMD
Enrollment
23
Registered
2022-04-15
Start date
2022-04-18
Completion date
2023-05-25
Last updated
2023-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duchenne Muscular Dystrophy

Keywords

Duchenne muscular dystrophy, Bicycle training, Gait, Balance

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.

Interventions

OTHERBicycle 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.

OTHERHome-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.

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Block Randomized controlled study

Eligibility

Sex/Gender
MALE
Age
5 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Velocity (Gait)5 minutesThe 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.
Step Time and Cycle Time(Gait)5 minutesThe 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)5 minutesThe 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)5 minutesThe 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 %.
Cadence (Gait)5 minutesThe 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)10 minutesThe 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)10 minutesThe 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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026