Pressure Pain Tolerance in Relation to Balance and Strength in Children

NCT06529874 | Recruiting

• 1 other identifier: P.T.REC/012/005092
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sickle Cell Anemia

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline of the study.

• 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.

  Baseline of the study.

• 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.

  Baseline of the study.

Study Arms (2)

Normal Healthy children

EXPERIMENTAL

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

Sickle cell anemia children

EXPERIMENTAL

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

Pressure pain tolerance measurement using Digital Pressure Algometer OTHER

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.

Normal Healthy children; Sickle cell anemia children

Balance assessment using HUMAC balance system OTHER

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 .

Normal Healthy children; Sickle cell anemia children

Lower limb muscular strength using Lafayette hand held dynamometer OTHER

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'

Normal Healthy children; Sickle cell anemia children

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 body mass index based on their age percentiles.
• All normal healthy children did not participating in regular sport activities, particularly including lower limb strengthening.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adly A Adam: lead

Study Sites (1)

El-Tahrir st.- in front of Ben El-Sarayat, Ad Doqi Al Giza, Giza Governate

Giza, 002, Egypt

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Shimaa A Ahmed, PHD

  Head of Haematology Dept, Faculty of Medicine, Alexandria University

  STUDY CHAIR

• Elham M Salem, PHD

  Professor of Physical Therapy, Faculty of Physical Therapy, Cairo University

  STUDY DIRECTOR

Central Study Contacts

Mahmoud M Metwaly, MD

CONTACT

0102572862; malmanakhly10@gmail.com

Nanees E Salem, PHD

CONTACT

0115960603; naness.essam@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Forty normal healthy children from primary governmental schools at Alexandria governate, and Forty children with sickle cell anemia from Alexandria University Students Hospitals.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer Physical Therapy

Model Details: An observational correlational study design.

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 31, 2024
• Study Start: February 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 30, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

EG (1)