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Completed

NCT Number: NCT05032703

Arm Ergometer Versus Stabilization Exercises on Trunk Control and Upper Extremity Functions in cp

The purposes of the current study are to:

Define and compare between the efficacy of arm ergometer versus stabilization exercises on trunk control, hand grip power and upper limb quality of functions in children with diplegia.

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Key information

Conditions

Spastic Diplegia Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of physical therapy - Cairo university

Giza, 12662, Egypt

About this study

Studies have shown that the cycle ergometer exercise improves several parameters, such as muscle strength and endurance, along with torso control in sitting position. However, these results are presented only in a small sample. Studies with the use of cycle ergometer in the population with CP are still few and present little information about the physiological effects .Previous studies on children with CP focused on the effect of ergometer on the upper and lower extremities functions. Limited literature is available regarding the effect of arm ergometer on trunk control among this population. The current study will be carried out to define the effect of arm ergometer versus stabilization exercises on trunk control, hand grip power, upper limb function in children with diplegia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ranges from six to ten years.
  • Grade of spasticity 1 to 2 according to Modified Ashworth scale.
  • Level II and III according to gross motor functional classification system.
  • Level I-III according to manual ability classification system.
  • Able to follow verbal commands and instructions included in both test and training.

Exclusion criteria

  • Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination).
  • Structural or fixed soft tissue deformities of the upper extremities.
  • Neurological or orthopedic surgery in the past 12 months in the upper extremities.
  • Botox injection in the upper extremities in the past 6 months.

Treatment and study plan

Arm ergometer

Device

The conventional physical therapy program included three sets of exercises as follows:

Flexibility exercises to restore joint mobility of soft tissues. Static and dynamic balance exercise. Functional walking exercises.

Other names: Stabilization exercises on BOSU ball

Primary outcomes

  1. Trunk control

    Time frame: 30 minutes

    Trunk control measurement scale includes 15 items that assess two main components of trunk control: static and dynamic sitting balance. While the total score is between 0 and 58, higher scores indicate a better level of performance.

  2. Upper extremity functions

    Time frame: 30/45 minutes

    Quality of upper extremity scale test which consist 34 items in four main domains: dissociated movement, grasp, protective extension, and weight bearing.

Secondary outcomes

  1. Hand grip strength

    Time frame: 5 minutes

    Hand held dynamometer used to measure muscle strength of the arm and hand in children with spastic CP. It is used to measure strength; maximal voluntary isometric contraction; objectively in kilograms, pounds or newtons.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Arm Ergometer Versus Stabilization Exercises on Trunk Control and Upper Extremity Functions in Children With Diplegia

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 2, 2021
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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