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RecruitingNCT06529874Updated Apr 1, 2025

Pressure Pain Tolerance in Relation to Balance and Strength in Children

An interventional study of Pressure pain tolerance measurement using Digital Pressure Algometer and Balance assessment using HUMAC balance system in Sickle Cell Anemia, sponsored by Adly A Adam. Recruiting at 1 site in Egypt. Open to participants aged 9 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by Adly A Adam · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Registered 5 months after the study started (first participant enrolled Feb 2024, registered Jul 2024).
  • Started Feb 2024; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
9 Years to 14 Years
Sex
All
01

Study summary

Sickle cell disease (SCD) is the most frequent life-threatening genetic hemoglobinopathy in the world and occurs due to the synthesis of abnormal hemoglobin S (HbS).Cells with sickle cell hemoglobin are stiff and sticky. When they lose their oxygen, they form into the shape of a sickle or crescent. This can cause pain and tissue damage. Significant decrease in exercise capacity was seen in sickle cell anemic children. In the absence of a guidelines that can guide the prescription of exercise in SCD children. This study is a step for determine the forms of prescription of pain on the balance and muscle strength to build up in future studies a safety of physical exercises for children with sickle cell anemia and improve their functional abilities.

Read the detailed description

Sickle cell anemia is a serious life-limiting and potentially life-threatening condition that causes disruption in the lifestyle of the affected child. Pain is a common and severe symptom of sickle cell disease (SCD) and is the major reason that patients seek health care services. Some researchers supported the fact that an important impairment in balance control and muscle strength in children with sickle cell disease due to pressure pain tolerance problems and other factors. Significant decrease in exercise capacity was seen in sickle cell anemic children. The altered muscle function and balance observed in SCD children may collectively be the result of pressure pain tolerance impairment. As your physical fitness improves, your body becomes more efficient at getting oxygen into the bloodstream and transporting it to the working muscles. Along this observational correlational study design; Eighty children from both sexes will be participated in this study. Forty normal healthy children will be selected from primary governmental schools at Alexandria governorate and forty children with sickle cell anemia will be selected from Alexandria University Students Hospitals For evaluation of muscle strength hand held dynamometer (Lafayette) is one of the best methods to detect the muscle strength. It is an ergonomic hand-held device for objectively quantifying muscle strength

02

Conditions studied

  • Sickle Cell Anemia

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03

In context

Anemia, Sickle Cell

1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.

This study's planned enrollment of 80 is above the median of 40 across 769 interventional studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

Adly A Adam is the lead sponsor of 12 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age range range was 9-14 years old.
  • Could follow given instructions.
  • Children with Sickle cell anemia were medically stable, and take their medications regularly.
  • Children with Sickle cell anemia had experience of chronic pain that lasts more than 6 months.
  • All children with Sickle cell anemia have average weight, height, and based on their age percentiles.
  • All normal healthy children did not participating in regular sport activities, particularly including lower limb strengthening.

Exclusion criteria

Exclusion Criteria:

  • Defined cardiovascular or respiratory disorders.
  • Renal failure.
  • Myocardial infarction, mainly within last month.
  • Unstable angina.
  • Recent thoracoabdominal surgery.
  • Thoracic or abdominal aneurysm or current pneumothorax.
  • Painful vaso-occlusive crises.
  • Muscular contractures, Joints' stiffness, or deformities.
  • Neuromuscular problems i.e., myositis or peripheral neuropathy.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Normal Healthy children

    All forty normal healthy children will undergo measurement of pressure pain tolerance via digital pressure algometry, balance assessment using HUMAC balance system, and evaluation lower limb strength using Lafayette Hand Held Dynamometer.

    Other: Pressure pain tolerance measurement using Digital Pressure Algometer · Other: Balance assessment using HUMAC balance system · Other: Lower limb muscular strength using Lafayette hand held dynamometer

  • Experimental
    Sickle cell anemia children

    All forty Sickle cell anemia children will undergo measurement of pressure pain tolerance via digital pressure algometry, balance assessment using HUMAC balance system, and evaluation lower limb strength using Lafayette Hand Held Dynamometer.

    Other: Pressure pain tolerance measurement using Digital Pressure Algometer · Other: Balance assessment using HUMAC balance system · Other: Lower limb muscular strength using Lafayette hand held dynamometer

Interventions

  • OtherPressure pain tolerance measurement using Digital Pressure Algometer

    Pressure pain tolerance will be measured using pressure algometer for all participants in both groups. Pressure pain tolerance will be measured in a relaxed sitting position to evaluate on quadriceps muscle. Initially, a teddy bear will be used for demonstration.

  • OtherBalance assessment using HUMAC balance system

    HUMAC balance system will be calibrated, then will conduct 1. center of pressure: will instructed child to stand on platform, and maintain own body stability, and focus on the red dot in the center of screen that will move in response to body sway. after a rest, second trial will be done. 2. Eye open/ closed firm surface tests: First for Eye open firm surface test; the child will be asked to look at a target on the wall that was set at his/ her eye level, and to stare at this target for 30 seconds while standing on firm surface. After 5 seconds rest. Eye closed firm surface test; child will be asked to close his/ her eyes for 30 seconds, and conducting the same procedures for balance testing. The researcher will documented the values resented on the screen .

  • OtherLower limb muscular strength using Lafayette hand held dynamometer

    Lower limb muscular ' Isometric quadriceps strength' will be measured for all participants in both groups. each participating child will be instructed to sit to assess the strength of knee extension, which minimize positional changes, and enhance feasibility of this clinical test. then The researcher will apply resistance to child's quadriceps to gain maximal voluntary isometric contraction with pressing the activated Lafayette hand held dynamometer padded stirrup against quadriceps belly, then recorded and documented measured value.

    Also known as: Isometric quadriceps strength'

06

What researchers measure

Primary outcomes

  1. Pressure pain tolerance

    Pressure pain tolerance measured via digital pressure algometer. It determines the pressure amount could be tolerated over quadriceps. This will represented chronic pain among Sickle cell anemia children in order to aid in diagnosis of hyperalgesia thus provide insight into their management strategies. Digital pressure algometer determines enables the rater to quantify the mechanical sensitivity to pain and the recovery of underlying problems or soreness levels in a semi-objective manner.

    Time frame: Baseline of the study.

  2. Balance assessment

    Balance assessed via HUMAC balance system to define musculoskeletal involvement in sickle cell anemia children. HUMAC balance system is an electronic balance board connected with laptop running HUMAC balance system software.

    Time frame: Baseline of the study.

  3. Lower limb muscle strength

    Lower limb muscle (Quadriceps) strength evaluated via Lafayette hand held dynamometer to evaluate voluntary isometric contraction. Hand held dynamometer has a good to excellent reliability and validity mainly for proximal musculatures.

    Time frame: Baseline of the study.

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06529874
Lead sponsor
Adly A Adam
Responsible party
Adly A Adam (Lecturer Physical Therapy, Cairo University) — Sponsor-investigator
First posted
Jul 31, 2024
Start date
Feb 1, 2024
Primary completion
Aug 1, 2025 (estimated)
Completion
Aug 30, 2025 (estimated)
Last update
Apr 1, 2025

Study contacts

Mahmoud M Metwaly, MD
Contact
malmanakhly10@gmail.com
0102572862
Nanees E Salem, PHD
Contact
naness.essam@gmail.com
0115960603
Shimaa A Ahmed, PHD
study chair · Head of Haematology Dept, Faculty of Medicine, Alexandria University
Elham M Salem, PHD
study director · Professor of Physical Therapy, Faculty of Physical Therapy, Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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