Spastic DiplegiaNCT05032703
Arm Ergometer Versus Stabilization Exercises on Trunk Control and Upper Extremity Functions in cp
A study testing Arm ergometer in people with Spastic Diplegia, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Spastic Diplegia
- What is being tested?
- Arm ergometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Nov 2021to 25 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Arm Ergometer Versus Stabilization Exercises on Trunk Control and Upper Extremity Functions in Children With Diplegia
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.
Read the 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.
- Conditions
- Spastic Diplegia
- Being tested
- Arm ergometer
- Keywords
- Cerebral palsy / Arm ergometer
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm ergometerDevice
Also called Stabilization exercises on BOSU ball
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Arm ergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30/45 minutes
Secondary outcomes (1)
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start18 Nov 2021
- Primary completion18 Apr 2023
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Spastic DiplegiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Nafea Mohie El Din, Cairo University
- Investigators
- Amira M Abd El Monem, Prof.dr, Study chair, Cairo UniversityAmira F Hamed, Dr, Study director, Cairo UniversityAhmed R Abdel Fadil, Dr, Study director, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032703
- Sponsor's protocol ID
- Arm ergometer in Cp
- Status last verified
- Aug 2023
- First submitted
- 31 Aug 2021
- Last updated
- 31 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15037681Baunsgaard 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.
PubMed 26857270Garcia 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.
PubMed 27162775Paulson 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.
PubMed 28441773dos 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.
PubMed 26314881Scholtes 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.
PubMed 20132136Unger 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.
PubMed 23477461
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Arm Ergometer Versus Stabilization Exercises on Trunk Control and Upper Extremity Functions in Children With Diplegia
- ClinicalTrials.gov ID
- NCT05032703
- Acronym / sponsor ID
- Arm ergometer in Cp
- Conditions
- Spastic Diplegia
- Keywords
- Cerebral palsy / Arm ergometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm ergometer | Experimental | Device: Arm ergometerChildren 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 | Experimental | Device: Arm ergometerChildren 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm ergometerAlso: Stabilization exercises on BOSU ballThe 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. | Device | Arm ergometer, Trunk stabilization exercise |
Primary outcome
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.
1 secondary outcome
Hand grip strength
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Background: PubMed 15037681Ashwal 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.
- Background: PubMed 26857270Baunsgaard 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.
- Background: PubMed 27162775Garcia 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.
- Background: PubMed 28441773Paulson 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.
- Background: PubMed 26314881dos 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.
- Background: PubMed 20132136Scholtes 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.
- Background: PubMed 23477461Unger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amira M Abd El Monem, Prof.dr study chair
Cairo University
Amira F Hamed, Dr study director
Cairo University
Ahmed R Abdel Fadil, Dr study director
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm ergometer in people with Spastic Diplegia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk control (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05032703, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.