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

Primary Purpose

Spastic Diplegia

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Arm ergometer

About this trial

This is an interventional treatment trial for Spastic Diplegia focused on measuring Cerebral palsy / Arm ergometer

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Faculty of physical therapy - Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm ergometer

Trunk stabilization exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Trunk control

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

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

Hand grip strength

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.

Full Information

NCT ID

NCT05032703

First Posted

August 31, 2021

Last Updated

August 29, 2023

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05032703

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

November 18, 2021 (Actual)

Primary Completion Date

April 18, 2023 (Actual)

Study Completion Date

May 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spastic Diplegia

Keywords

Cerebral palsy / Arm ergometer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Masking Description

Single blind

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm ergometer

Arm Type

Experimental

Arm Description

Arm Title

Trunk stabilization exercise

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Arm ergometer

Other Intervention Name(s)

Stabilization exercises on BOSU ball

Intervention Description

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.

Primary Outcome Measure Information:

Title

Trunk control

Description

Time Frame

30 minutes

Title

Upper extremity functions

Description

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

Time Frame

30/45 minutes

Secondary Outcome Measure Information:

Title

Hand grip strength

Description

Time Frame

5 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amira M Abd El Monem, Prof.dr

Organizational Affiliation

Cairo University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Amira F Hamed, Dr

Organizational Affiliation

Cairo University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Ahmed R Abdel Fadil, Dr

Organizational Affiliation

University of Alexandria

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of physical therapy - Cairo university

City

Giza

ZIP/Postal Code

12662

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

15037681

Citation

Ashwal S, Russman BS, Blasco PA, Miller G, Sandler A, Shevell M, Stevenson R; Quality Standards Subcommittee of the American Academy of Neurology; Practice Committee of the Child Neurology Society. Practice parameter: diagnostic assessment of the child with cerebral palsy: report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2004 Mar 23;62(6):851-63. doi: 10.1212/01.wnl.0000117981.35364.1b.

Results Reference

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PubMed Identifier

26857270

Citation

Baunsgaard CB, Nissen UV, Christensen KB, Biering-Sorensen F. Modified Ashworth scale and spasm frequency score in spinal cord injury: reliability and correlation. Spinal Cord. 2016 Sep;54(9):702-8. doi: 10.1038/sc.2015.230. Epub 2016 Feb 9.

Results Reference

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PubMed Identifier

27162775

Citation

Garcia CC, Alcocer-Gamboa A, Ruiz MP, Caballero IM, Faigenbaum AD, Esteve-Lanao J, Saiz BM, Lorenzo TM, Lara SL. Metabolic, cardiorespiratory, and neuromuscular fitness performance in children with cerebral palsy: A comparison with healthy youth. J Exerc Rehabil. 2016 Apr 26;12(2):124-31. doi: 10.12965/jer.1632552.276. eCollection 2016 Apr.

Results Reference

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PubMed Identifier

28441773

Citation

Paulson A, Vargus-Adams J. Overview of Four Functional Classification Systems Commonly Used in Cerebral Palsy. Children (Basel). 2017 Apr 24;4(4):30. doi: 10.3390/children4040030.

Results Reference

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PubMed Identifier

26314881

Citation

dos Santos LJ, de Aguiar Lemos F, Bianchi T, Sachetti A, Dall' Acqua AM, da Silva Naue W, Dias AS, Vieira SR. Early rehabilitation using a passive cycle ergometer on muscle morphology in mechanically ventilated critically ill patients in the Intensive Care Unit (MoVe-ICU study): study protocol for a randomized controlled trial. Trials. 2015 Aug 28;16:383. doi: 10.1186/s13063-015-0914-8.

Results Reference

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PubMed Identifier

20132136

Citation

Scholtes VA, Becher JG, Comuth A, Dekkers H, Van Dijk L, Dallmeijer AJ. Effectiveness of functional progressive resistance exercise strength training on muscle strength and mobility in children with cerebral palsy: a randomized controlled trial. Dev Med Child Neurol. 2010 Jun;52(6):e107-13. doi: 10.1111/j.1469-8749.2009.03604.x. Epub 2010 Feb 12.

Results Reference

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PubMed Identifier

23477461

Citation

Unger M, Jelsma J, Stark C. Effect of a trunk-targeted intervention using vibration on posture and gait in children with spastic type cerebral palsy: a randomized control trial. Dev Neurorehabil. 2013;16(2):79-88. doi: 10.3109/17518423.2012.715313.

Results Reference

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

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