NCT05032703

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

November 18, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2023

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

1.4 years

First QC Date

August 31, 2021

Last Update Submit

August 29, 2023

Conditions

Spastic Diplegia

Keywords

Cerebral palsy / Arm ergometer

Outcome Measures

Primary Outcomes (2)

  • 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.

    30 minutes

  • 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.

    30/45 minutes

Secondary Outcomes (1)

  • Hand grip strength

    5 minutes

Study Arms (2)

Arm ergometer

EXPERIMENTAL

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.

Device: Arm ergometer

Trunk stabilization exercise

EXPERIMENTAL

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.

Device: Arm ergometer

Interventions

Arm ergometerDEVICE

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.

Also known as: Stabilization exercises on BOSU ball
Arm ergometerTrunk stabilization exercise

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy - Cairo university

Giza, 12662, Egypt

Location

Related Publications (7)

  • 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.

    PMID: 15037681BACKGROUND

  • 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.

    PMID: 26857270BACKGROUND

  • 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.

    PMID: 27162775BACKGROUND

  • 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.

    PMID: 28441773BACKGROUND

  • 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.

    PMID: 26314881BACKGROUND

  • 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.

    PMID: 20132136BACKGROUND

  • 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.

    PMID: 23477461BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Amira M Abd El Monem, Prof.dr

    Cairo University

    STUDY CHAIR

  • Amira F Hamed, Dr

    Cairo University

    STUDY DIRECTOR

  • Ahmed R Abdel Fadil, Dr

    University of Alexandria

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Reham Nafea master degree, faculty of physical therapy

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 2, 2021

Study Start

November 18, 2021

Primary Completion

April 18, 2023

Study Completion

May 25, 2023

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)