Healthy IndividualsNCT07054853
Effect of Induced Rotator Cuff Muscles Fatigue on Hand Grip Strength in Adults
An observational study of Healthy Individuals, run by Noura Karam Abdou Mohammed Ismaiel at 1 site in Egypt.
Trial summary
This observational study aims to investigate the effect of induced rotator cuff muscles fatigue on hand grip strength in adults Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- Induced rotator cuff fatigue by isokinetic biodex
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Sep 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy Individuals
Who may be able to join
- Both male and females (18-30) years
- No complaints of existing shoulder pathology/pain in at least one shoulder within the last 6 months, no back pain, no history of shoulder/thoracic spine surgery, and no spinal deformities
- Body mass index between (18.5:24.99) Kg/ m2
Who cannot join
- Shoulder complaints in the past 6 months such as shoulder dislocation rotator cuff tear, shoulder surgery, and shoulder rehabilitation or other upper limb forms of disability
- Subjects who had wrist pain, a joint injury, undergone surgery, or neuromuscular dysfunction were excluded from the study
- Individuals who suffered an injury or underwent a surgical procedure in the last six months that could affect hand functions or senses
Trial locations and contacts
1 site in 1 country.
About this study
This observational study aims to investigate the effect of induced rotator cuff muscles fatigue on hand grip strength in adults
Read the detailed description
This study is set to take place at the Isokinetic Biodex Laboratory, Faculty of Physical Therapy at Misr University for Science and Technology (MUST). The goal is to explore how fatigue in the rotator cuff muscles affects hand grip strength in healthy adults.
The study will involve 30 healthy male and female participants, aged between 18 and 30 years, all recruited from the university. To ensure the reliability of the results, participants must meet specific inclusion criteria: they should have no recent history of shoulder or back pain, no spinal deformities, and a body mass index within the normal range. Individuals with any upper limb disorders, recent surgeries, or neurological issues will be excluded.
The experimental protocol is carefully structured and will be conducted using two key tools. The first is the Biodex System 4 Pro, an isokinetic dynamometer renowned for its accuracy in measuring muscle performance and fatigue. The second is the Jamar Plus+ Digital, a gold-standard device for measuring grip strength, known for its reliability and ease of use.
Participants will attend two fatigue sessions apart to prevent carryover effects. Each session will involve a fatigue protocol by isokinetic biodex system targeting the shoulder's internal and external rotators at two different abduction angles: 30° (Protocol A) and 90° (Protocol B).
Grip strength will be assessed both before and after each fatigue session using the Jamar plus+ Digital. Participants will sit with their arms and legs positioned for standardized testing, and each will complete three maximal grip trials. The average of these attempts will be recorded, with verbal encouragement provided to ensure maximal effort.
Through this structured investigation, the study aims to shed light on how rotator cuff fatigue influences hand grip strength-an insight that could have practical implications for injury prevention, rehabilitation strategies, and performance optimization in both clinical and athletic settings.
- Conditions
- Healthy Individuals
- Being tested
- Induced rotator cuff fatigue by isokinetic biodex
- Keywords
- muscle fatigue, neuromuscular performance, isokinetic biodex, hand grip strength, rotator cuff muscles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induced rotator cuff fatigue by isokinetic biodexDevice
Each subject will undergo two separate fatigue protocols from distinct shoulder abduction angles (30° and 90°), referred to as Protocol A and Protocol B, respectively.
Fatigue will be induced using the Biodex System 4 Pro Isokinetic .Participants will be seated with the tested arm positioned at the designated shoulder abduction angle and elbow flexed at 90°. The arm will be secured using a shoulder adapter to ensure standardized positioning. Hand Grip strength will be assessed using a Jamar Plus+ Digital. Participants will perform three maximal grip trials, each lasting 3 seconds, with verbal encouragement provided. The average of the three trials will be used as the maximum voluntary contraction
| Study group | Role | What they receive |
|---|---|---|
| one group males and females | Not described Receives: Device: Induced rotator cuff fatigue by isokinetic biodex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Grip Strength
Maximum Voluntary Contraction
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start25 Sep 2025
- Primary completion30 Oct 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noura Karam Abdou Mohammed Ismaiel
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, Misr University for Science and Technology
- Responsible party
- Sponsor-investigator, Noura Karam Abdou Mohammed Ismaiel, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054853
- Sponsor's protocol ID
- P.T.REC/012/005798
- Status last verified
- Mar 2026
- First submitted
- 27 Jun 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Induced Rotator Cuff Muscles Fatigue on Hand Grip Strength in Adults
- ClinicalTrials.gov ID
- NCT07054853
- Acronym / sponsor ID
- P.T.REC/012/005798
- Conditions
- Healthy Individuals
- Keywords
- muscle fatigue, neuromuscular performance, isokinetic biodex, hand grip strength, rotator cuff muscles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Noura Karam Abdou Mohammed IsmaielUniversity, hospital or other
- Collaborators
- Cairo University, Misr University for Science and Technology
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 8 Jul 2025 (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.
This observational study aims to investigate the effect of induced rotator cuff muscles fatigue on hand grip strength in adults
Detailed description
This study is set to take place at the Isokinetic Biodex Laboratory, Faculty of Physical Therapy at Misr University for Science and Technology (MUST). The goal is to explore how fatigue in the rotator cuff muscles affects hand grip strength in healthy adults.
The study will involve 30 healthy male and female participants, aged between 18 and 30 years, all recruited from the university. To ensure the reliability of the results, participants must meet specific inclusion criteria: they should have no recent history of shoulder or back pain, no spinal deformities, and a body mass index within the normal range. Individuals with any upper limb disorders, recent surgeries, or neurological issues will be excluded.
The experimental protocol is carefully structured and will be conducted using two key tools. The first is the Biodex System 4 Pro, an isokinetic dynamometer renowned for its accuracy in measuring muscle performance and fatigue. The second is the Jamar Plus+ Digital, a gold-standard device for measuring grip strength, known for its reliability and ease of use.
Participants will attend two fatigue sessions apart to prevent carryover effects. Each session will involve a fatigue protocol by isokinetic biodex system targeting the shoulder's internal and external rotators at two different abduction angles: 30° (Protocol A) and 90° (Protocol B).
Grip strength will be assessed both before and after each fatigue session using the Jamar plus+ Digital. Participants will sit with their arms and legs positioned for standardized testing, and each will complete three maximal grip trials. The average of these attempts will be recorded, with verbal encouragement provided to ensure maximal effort.
Through this structured investigation, the study aims to shed light on how rotator cuff fatigue influences hand grip strength-an insight that could have practical implications for injury prevention, rehabilitation strategies, and performance optimization in both clinical and athletic settings.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group males and females | – | Device: Induced rotator cuff fatigue by isokinetic biodex |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy Individuals
Key inclusion criteria (3 listed)
- Both male and females (18-30) years
- No complaints of existing shoulder pathology/pain in at least one shoulder within the last 6 months, no back pain, no history of shoulder/thoracic spine surgery, and no spinal deformities
- Body mass index between (18.5:24.99) Kg/ m2
Key exclusion criteria (3 listed)
- Shoulder complaints in the past 6 months such as shoulder dislocation rotator cuff tear, shoulder surgery, and shoulder rehabilitation or other upper limb forms of disability
- Subjects who had wrist pain, a joint injury, undergone surgery, or neuromuscular dysfunction were excluded from the study
- Individuals who suffered an injury or underwent a surgical procedure in the last six months that could affect hand functions or senses
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 |
|---|---|---|
| Induced rotator cuff fatigue by isokinetic biodexEach subject will undergo two separate fatigue protocols from distinct shoulder abduction angles (30° and 90°), referred to as Protocol A and Protocol B, respectively. Fatigue will be induced using the Biodex System 4 Pro Isokinetic .Participants will be seated with the tested arm positioned at the designated shoulder abduction angle and elbow flexed at 90°. The arm will be secured using a shoulder adapter to ensure standardized positioning. Hand Grip strength will be assessed using a Jamar Plus+ Digital. Participants will perform three maximal grip trials, each lasting 3 seconds, with verbal encouragement provided. The average of the three trials will be used as the maximum voluntary contraction | Device | one group males and females |
Primary outcome
Hand Grip Strength
Time frame: 3 months
Maximum Voluntary Contraction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Individuals, run by Noura Karam Abdou Mohammed Ismaiel 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 30 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Grip Strength (time frame: 3 months). 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 30 Mar 2026.