Sickle Cell AnemiaNCT06529874
Pressure Pain Tolerance in Relation to Balance and Strength in Children
A study testing Pressure pain tolerance measurement using Digital Pressure Algometer, Balance assessment using HUMAC balance system and Lower limb muscular strength using Lafayette hand held dynamometer in people with Sickle Cell Anemia, run by Adly A Adam at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Anemia
- What is being tested?
- Pressure pain tolerance measurement using Digital Pressure Algometer, Balance assessment using HUMAC balance system and Lower limb muscular strength using Lafayette hand held dynamometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- Painful vaso-occlusive crises.
- Muscular contractures, Joints' stiffness, or deformities.
- Neuromuscular problems i.e., myositis or peripheral neuropathy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
El-Tahrir st.- in front of Ben El-Sarayat, Ad Doqi Al Giza, Giza Governate
Giza, 002
Mahmoud M Metwaly, MD, 01025702861, mamanakhly18@gmail.com
Nanees E Salem, PHD, 01115960603, naness.esam@gmail.com
About this study
Official title: Pressure Pain Tolerance in Relation to Balance and Strength in Children With Sickle Cell Anemia
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
- Conditions
- Sickle Cell Anemia
- Being tested
- Pressure pain tolerance measurement using Digital Pressure Algometer, Balance assessment using HUMAC balance system, Lower limb muscular strength using Lafayette hand held dynamometer
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure pain tolerance measurement using Digital Pressure AlgometerOther
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 systemOther
HUMAC balance system will be calibrated, then will conduct
- 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.
- 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 dynamometerOther
Also called Isometric quadriceps strength'
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Feb 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- An observational correlational study design.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adly A Adam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adly A Adam, Cairo University
- Investigators
- Shimaa A Ahmed, PHD, Study chair, Head of Haematology Dept, Faculty of Medicine, Alexandria UniversityElham M Salem, PHD, Study director, Professor of Physical Therapy, Faculty of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529874
- Sponsor's protocol ID
- P.T.REC/012/005092
- Status last verified
- Mar 2025
- First submitted
- 25 Jul 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Pain Tolerance in Relation to Balance and Strength in Children With Sickle Cell Anemia
- ClinicalTrials.gov ID
- NCT06529874
- Acronym / sponsor ID
- P.T.REC/012/005092
- Conditions
- Sickle Cell Anemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Adly A AdamUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An observational correlational study design.
| Arm | Type | Receives |
|---|---|---|
| Normal Healthy children | Experimental | 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 dynamometerAll 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. |
| Sickle cell anemia children | Experimental | 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 dynamometerAll 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. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- Defined cardiovascular or respiratory disorders.
- Renal failure.
- Myocardial infarction, mainly within last month.
- Unstable angina.
- Recent thoracoabdominal surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure pain tolerance measurement using Digital Pressure AlgometerPressure 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. | Other | Normal Healthy children, Sickle cell anemia children |
| Balance assessment using HUMAC balance systemHUMAC 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 . | Other | Normal Healthy children, Sickle cell anemia children |
| Lower limb muscular strength using Lafayette hand held dynamometerAlso: Isometric quadriceps strength'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. | Other | Normal Healthy children, Sickle cell anemia children |
Primary outcome
Pressure pain tolerance
Time frame: Baseline of the study.
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.
Balance assessment
Time frame: Baseline of the study.
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.
Lower limb muscle strength
Time frame: Baseline of the study.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure pain tolerance measurement using Digital Pressure Algometer, Balance assessment using HUMAC balance system and Lower limb muscular strength using Lafayette hand held dynamometer in people with Sickle Cell Anemia, run by Adly A Adam at 1 site in Egypt.
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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 1 Apr 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud M Metwaly, MD (0102572862, malmanakhly10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain tolerance (time frame: Baseline of the study.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2025.