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

Not Applicable

Completed

• Conditions: Spastic Diplegia
• Interventions: Device: Arm ergometer

• Registration Number: NCT05032703
• Lead Sponsor: Cairo University

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 Timeline

• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2021-08-31
• Study First Posted: 2021-09-02
• Study Start: 2021-11-18
• Primary Completion: 2023-04-18
• Study Completion: 2023-05-25
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm ergometer	Arm ergometer	Children in group I will receive strength-endurance protocol of arm ergometer for 30 minutes in addition to the conventional physical therapy program for 30 minutes, per session, three times a week, for three consecutive months.
Trunk stabilization exercise	Arm ergometer	Children in group II will receive trunk stabilization exercises for 30 minutes in addition to the conventional physical therapy program for 30 minutes, per session, three times a week, for three consecutive months.

Primary Outcome Measures

Name	Time	Method
Trunk control	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	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 Outcome Measures

Name	Time	Method
Hand grip strength	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.

Trial Locations

Locations (1)

Faculty of physical therapy - Cairo university; 🇪🇬 Giza, Egypt