Pressure Pain Tolerance in Relation to Balance and Strength in Children

NCT ID: NCT06529874

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-08-30

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.

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

Conditions

Sickle Cell Anemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pressure pain tolerance measurement using Digital Pressure Algometer

Intervention Type: 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.

Balance assessment using HUMAC balance system

Intervention Type: 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 .

Lower limb muscular strength using Lafayette hand held dynamometer

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Pressure pain tolerance measurement using Digital Pressure Algometer

Intervention Type: 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.

Balance assessment using HUMAC balance system

Intervention Type: 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 .

Lower limb muscular strength using Lafayette hand held dynamometer

Intervention Type: 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.

Interventions

Pressure 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.

Intervention Type: OTHER

Balance 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 .

Intervention Type: OTHER

Lower 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.

Intervention Type: OTHER

Other Intervention Names

Isometric quadriceps strength'

Eligibility Criteria

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

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Adly A Adam

OTHER

Sponsor Role: lead

Responsible Party

Adly A Adam

Lecturer Physical Therapy

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shimaa A Ahmed, PHD

Role: STUDY_CHAIR

Head of Haematology Dept, Faculty of Medicine, Alexandria University

Elham M Salem, PHD

Role: STUDY_DIRECTOR

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

Locations

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

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mahmoud M Metwaly, MD

Role: CONTACT

malmanakhly10@gmail.com

0102572862

Nanees E Salem, PHD

Role: CONTACT

naness.essam@gmail.com

0115960603

Facility Contacts

Mahmoud M Metwaly, MD

Role: primary

mamanakhly18@gmail.com

01025702861

Nanees E Salem, PHD

Role: backup

naness.esam@gmail.com

01115960603

Other Identifiers

P.T.REC/012/005092

Identifier Type: -

Identifier Source: org_study_id