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

NCT ID: NCT05032703

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-18

Study Completion Date

2023-05-25

Brief Summary

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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

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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.

Conditions

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Spastic Diplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Single blind

Study Groups

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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.

Group Type EXPERIMENTAL

Arm ergometer

Intervention Type 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.

Trunk stabilization exercise

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.

Group Type EXPERIMENTAL

Arm ergometer

Intervention Type 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.

Interventions

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Arm ergometer

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.

Intervention Type DEVICE

Other Intervention Names

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Stabilization exercises on BOSU ball

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Reham Nafea Mohie El Din

Dr Reham Nafea master degree, faculty of physical therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amira M Abd El Monem, Prof.dr

Role: STUDY_CHAIR

Cairo University

Amira F Hamed, Dr

Role: STUDY_DIRECTOR

Cairo University

Ahmed R Abdel Fadil, Dr

Role: STUDY_DIRECTOR

University of Alexandria

Locations

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Faculty of physical therapy - Cairo university

Giza, , Egypt

Site Status

Countries

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Egypt

References

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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 [RETIRED]: 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.

Reference Type BACKGROUND
PMID: 15037681 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26857270 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27162775 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28441773 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26314881 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20132136 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23477461 (View on PubMed)

Other Identifiers

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Arm ergometer in Cp

Identifier Type: -

Identifier Source: org_study_id

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