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Clinical Trials/NCT05032703
NCT05032703CompletedNot Applicable

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

Cairo University2 sites in 1 country42 target enrollmentStarted: November 18, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
42
Locations
2
Primary Endpoint
Trunk control

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

Single blind

Eligibility Criteria

Ages
6 Years to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

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

  • Hand grip strength(5 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Reham Nafea Mohie El Din

Dr Reham Nafea master degree, faculty of physical therapy

Cairo University

Study Sites (2)

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