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Cerebral PalsyNCT05321797

Aerobic Training On Spasticity And Gross Motor Function In Children With Diplegic Cerebral Palsy

A study testing Aerobic Training and Conventional Physiotherapy in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine the effects of aerobic training on spasticity and gross motor function in children with diplegic Cerebral palsy.Cerebral palsy (CP) is a neurodevelopmental disorder characterized by abnormalities of muscle tone, movement and motor skills, and is attributed to injury to the developing brain. . Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Aerobic Training and Conventional Physiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 sitePakistan
Study dates
30 Nov 2021to 31 Jul 2022
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 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 6-12 years of age both genders will be included.
  • Ability to follow simple verbal instructions.
  • Ability to walk independently, with or without an assistive device, for short distances (gross motor function classification system [gmfcs] levels i-iii)
  • Spastic Diplegic Cerebral Palsy scoring on Ashworth Scale of 1, 1±, 2

Who cannot join

  • Orthopedic surgery, neurological surgery, or baclofen pump implantation within the preceding 12 months
  • Botulinum toxin injections within the preceding 3 months
  • Serial casting or new orthotic devices within the preceding 3 months
  • Initiation of oral medications that affect the neuromuscular system (eg, baclofen) within the preceding 3 months
  • Inability or unwillingness to maintain age appropriate behavior
  • Serious medical conditions such as cardiac disease, diabetes, or uncontrolled seizures
  • Significant hip, knee, or ankle joint contractures preventing passive movement of the lower limbs through the pedaling cycle

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Physiogic Physiotherapy Clinic

    Lahore, Punjab Province, 64000

Other trials in Pakistan

About this study

Official title: Effects Of Aerobic Training On Spasticity And Gross Motor Function In Children With Diplegic Cerebral Palsy

To determine the effects of aerobic training on spasticity and gross motor function in children with diplegic Cerebral palsy.Cerebral palsy (CP) is a neurodevelopmental disorder characterized by abnormalities of muscle tone, movement and motor skills, and is attributed to injury to the developing brain. . The spastic CP is found to be the commonest presentation followed by athetoid, ataxic and mixed types. Children with cerebral palsy (CP) have decreased capacity to participate in play and sports activities .Reduced capacity to perform typical childhood activities contributes to low habitual physical activity and declining gross motor function in adolescence. Exercise opportunities are restricted in the population of cerebral palsy with spasticity, and so muscle strength may be reduced by disuse. Aerobic Training via Lower-extremity cycling is a rehabilitation tool used by physical therapists to improve spasticity, gross motor function and cardio-respiratory fitness, appears well-suited as a therapeutic intervention for children with CP. The tools used will be GMFM-66 and Modified Ashworth Scale. Study will be conducted on Thirty two patients in two Groups. Group A will be Control Group that will be provided with conventional physiotherapy (Stretching exercises , Trunk control training, walk and breathing exercises) and Group B will be Experimental Group that will be provided with conventional physiotherapy with cycling for 30 minutes with three sessions per week over the period of 12 weeks. Data will be analyzed using spss 22.0.

Conditions
Cerebral Palsy
Being tested
Aerobic Training, Conventional Physiotherapy
Keywords
Aerobic Training, Gross Motor Function, Stationary Cycle, Diplegic Cerebral Palsy
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic TrainingOther

    This group will be administered with the cycling exercises in addition to the complete plan of care that is being administered to the control group. The cycling intervention will be performed 3 times per week, for 30 minutes, within a 12-week period

  • Conventional PhysiotherapyOther

    This group will be administered with Conventional Physiotherapy that includes 5 minutes of stretching exercises for quadriceps, hamstrings and gastrocnemius, 5 minutes of trunk control training, 5 minutes walking in the hall with and without the therapist assistance, walker or crutches, and finally 5 minutes of breathing exercises for Relaxation

Study groups in NCT05321797
Study groupRoleWhat they receive
Aerobic Training GroupExperimentalCycling exercise group along with Conventional therapy
Receives: Other: Aerobic Training; Other: Conventional Physiotherapy
Conventional PhysiotherapyActive comparatorStrectching with ROM and gait training
Receives: Other: Conventional Physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gross Motor Function Measure (GMFM-66)

    The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. SCORING KEY 0 = does not initiate 1 = initiates 2 = partially completes 3 = completes 9 (or leave blank) = not tested (NT).

    Measured: 8th Week

  2. Modified Ashworth Scale (MAS)

    The modified Ashworth scale(MAS) is a 6-point rating scale that is used to measure muscle tone.(20) The reliability of the modified Ashworth scale was very good reliability and validity

    Measured: 8th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2022
  2. Study start30 Nov 2021
  3. Primary completion30 Jun 2022
  4. Study completion31 Jul 2022

Resources

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05321797
Sponsor's protocol ID
REC/RCR & AHS/21/0702
Status last verified
Jun 2023
First submitted
2 Apr 2022
Last updated
28 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Damiano DL, Stanley CJ, Ohlrich L, Alter KE. Task-Specific and Functional Effects of Speed-Focused Elliptical or Motor-Assisted Cycle Training in Children With Bilateral Cerebral Palsy: Randomized Clinical Trial. Neurorehabil Neural Repair. 2017 Aug;31(8):736-745. doi: 10.1177/1545968317718631. Epub 2017 Jul 8.

    PubMed 28691601

  • Fowler EG, Knutson LM, Demuth SK, Siebert KL, Simms VD, Sugi MH, Souza RB, Karim R, Azen SP; Physical Therapy Clinical Research Network (PTClinResNet). Pediatric endurance and limb strengthening (PEDALS) for children with cerebral palsy using stationary cycling: a randomized controlled trial. Phys Ther. 2010 Mar;90(3):367-81. doi: 10.2522/ptj.20080364. Epub 2010 Jan 21.

    PubMed 20093327

  • Fujimoto J, Umemoto Y, Koike Y, Isida K, Sakamoto K, Tajima F. Immediate effects of short period lower limb ergometer exercise in adolescent and young adult patients with cerebral palsy and spastic diplegia. J Phys Ther Sci. 2021 Jan;33(1):52-56. doi: 10.1589/jpts.33.52. Epub 2021 Jan 5.

    PubMed 33519075

  • da Rosa Pinheiro DR, Cabeleira MEP, da Campo LA, Correa PS, Blauth AHEG, Cechetti F. Effects of aerobic cycling training on mobility and functionality of acute stroke subjects: A randomized clinical trial. NeuroRehabilitation. 2021;48(1):39-47. doi: 10.3233/NRE-201585.

    PubMed 33386826

  • El-Tamawy MS, Darwish MH, Basheer MA, Reda AM, Elzanaty M, Khalifa HA. Effect of cycling exercise on motor excitability and gait abnormalities in stroke patients. The Egyptian Journal of Neurology, Psychiatry and Neurosurgery. 2021;57(1):1-7

  • Armstrong EL, Spencer S, Kentish MJ, Horan SA, Carty CP, Boyd RN. Efficacy of cycling interventions to improve function in children and adolescents with cerebral palsy: a systematic review and meta-analysis. Clin Rehabil. 2019 Jul;33(7):1113-1129. doi: 10.1177/0269215519837582. Epub 2019 Apr 2.

    PubMed 30935240

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Training and Conventional Physiotherapy in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.

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 4 inclusion and 7 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 28 Jun 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 Pakistan. 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?

Gross Motor Function Measure (GMFM-66) (time frame: 8th Week). 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 NCT05321797, which also lists 6 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 28 Jun 2023.

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