NCT05577286

Brief Summary

Despite the benefits of physical rehabilitation among adults and children with chronic illness such as Diabetes mellitus avoid engaging in different physical activities especially pediatric population. Most of the children with type 1 Diabetes mellitus receive their medical treatment and follow-up with no change of their functional performance.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

December 2, 2022

Status Verified

December 1, 2022

Enrollment Period

29 days

First QC Date

September 27, 2022

Last Update Submit

December 1, 2022

Conditions

Keywords

Diabetes mellitustype 1 1 Diabetes mellitusplyometric exercisesbalancemuscle strength

Outcome Measures

Primary Outcomes (2)

  • muscle strength

    assessment of hip, knee and ankle muscles by The Laffayette manual muscle testing (model 01163 USA) which measure strength in kG.

    after 3 successive months

  • balance

    assessment of balance by The Human Assessment Computer (HUMAC), a computerized dynamic posturography (commuter sports medicine, Inc., Stoughton, MA).

    after 3 successive months

Study Arms (2)

control group

OTHER

15 Children with type 1 Diabetes mellitus in this group will receive the regular medical treatment without change of their daily activity routine

Other: regular care

plyometric group

EXPERIMENTAL

15 Children with type 1 Diabetes mellitus in this group will receive the regular medical treatment as in control group in addition to a designed plyometric training program for 30 minutes, three times a week for two successive months.

Other: regular careOther: plyometric training

Interventions

the regular medical treatment without change of their daily activity routine

control groupplyometric group

designed plyometric training program for 30 minutes, three times a week for two successive months

plyometric group

Eligibility Criteria

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

You may qualify if:

  • Age will range from six to 10 years
  • Both sexes
  • Chronicity of the disease ranges from 3 to \<5 years.
  • Controlled diabetes with insulin dosage described by physician.

You may not qualify if:

  • Heriderty sensory or autonomic peripheral neuropathy.
  • Unstable cardio-vascular disorders
  • History of fractures or surgery in the lower extremities in the past 12 months.
  • Diagnosed with other hormonal diseases.
  • Children who practice regular sports.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Interventions

Plyometric Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Doaa A Mahmoud Sanad, Phd

    Cairo university, faculty of physical therapy

    STUDY CHAIR
  • Samya M Aly Hussein, B.Sc.

    Cairo university, faculty of physical therapy

    PRINCIPAL INVESTIGATOR
  • Aboalnaga A Abdelrahim Hamed

    Cairo university, faculty of physical therapy

    STUDY DIRECTOR

Central Study Contacts

Amira M Abd-elmonem, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof. Physical therapy for pediatric department, faculty of physical therapy , Cairo university

Study Record Dates

First Submitted

September 27, 2022

First Posted

October 13, 2022

Study Start

January 1, 2023

Primary Completion

January 30, 2023

Study Completion

November 30, 2024

Last Updated

December 2, 2022

Record last verified: 2022-12