Proprioceptive DisordersNCT04470362
Effect of Proprioceptive Training on Muscle Fatigue in Older Adults
A study testing Isokinetic dynamometer in people with Proprioceptive Disorders, run by Ayman Mohamed at 1 site in Egypt.
Trial summary
Summary Muscle fatigue is a serious problem commonly occur in older ages. Muscle fatigue disturbs both daily life activities and rehabilitation tolerance in elderlies. Muscle fatigue happens due to the motor or sensory dysfunctions. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Proprioceptive Disorders
- What is being tested?
- Isokinetic dynamometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 1 Sep 2021
- Phase
- Interventional
- 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Elderlies over 65 years old
Who cannot join
- No previous history of lower extremity trauma, serious metabolic, neurological, muscular, inflammatory or cardiovascular diseases
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Beni Suef University
Banī Suwayf, Beni Suweif Governorate, 43561
Ibrahim Ragab, 01003068518, Ibrahim.Ragab982@gmail.com
Ayman, 0100306818, dr_ayman_pt@hotmail.com
About this study
Official title: Beni-Suef University
Summary Muscle fatigue is a serious problem commonly occur in older ages. Muscle fatigue disturbs both daily life activities and rehabilitation tolerance in elderlies. Muscle fatigue happens due to the motor or sensory dysfunctions. The previous interventions focused mainly on the motor causes of muscle fatigue, however the important role of the sensory system in driving the motor system. It has been demonstrated that proprioceptors are mainly responsible for sensing the muscle fatigue. Objectives: This study will be conducted to investigate 1. The effect of proprioception training on reducing the occurrence of muscle fatigue in elderlies. 2. The effect of proprioceptive training on delaying the deterioration in electromyographical data from muscles of lower limbs.
Read the detailed description
Study protocol A single blinded randomized parallel study design will be used in this study. 40 participants will be recruited for this study aged from 65 to 90 years old. The randomization will be performed using simple envelop methods. Participants will be divided into two groups, control and study groups. The control group will receive an isokinetic strengthening program for the quadriceps muscles. Twenty-four strengthening session will be performed using an isokinetic device. The exercise program begins with 60% of the mean peak torque, and the patient reaches this intensity by auditory biofeedback. An increasing dose program will be used in the first 5 sessions (1 set to 5 sets), and a dose of 6 sets will be applied from the sixth to twenty-fourth sessions, with the density rising from 60% to 80% of the mean peak torque according to the patient tolerance. Each set consisted of 5 repetitions of concentric (Con/Ecc) contraction in angular velocities of 30°/second and 120°/second for extensors. This program accomplished significant results in increasing the quadriceps power and strength.
Participants in the study group will perform the same exercise parameters used in the control group but in a different manner. The isokinetic exercise will be done with a closed eye to improve the proprioception function. This exercise will be performed for 6 sets. We will add another set, in which the participant will be instructed that the range of motion of the knee joint will be divided into three ranges, the outer range (from 0 to 90 degrees of knee flexion), the middle range (90 degrees of flexion) and inner range (from 90 degrees to 145 degree of flexion). During this set, the isokinetic device will be stopped at a different joint angle and the participant will be asked to identify at which range the knee joint is in. This modification is directed to improve the function of muscle spindles and Golgi tendon organs.
Additional training will be performed by the application of three vibrators above and on both sides of the knee joint to improve the function of the Pacinian and Meissner corpuscles which is one of the included receptors in the sensation of the fatigue. This vibration will be set at a subsensory intensity (Stochastic theory39) and a frequency fluctuating frequency from 50 Hz to 250 Hz to train both receptors40 and it will be performed for 20 min/each session. This programs will be performed for three sessions/week for two months.
The primary outcomes measure will be the electromyographical analysis of quadriceps muscle at the onset of muscle fatigue and after recovery. The secondary outcome measures will include the Fatigue Index (FI) and the Rating-of-Fatigue Scale. These measurements at baseline, After one month, After two months.
- Conditions
- Proprioceptive Disorders
- Being tested
- Isokinetic dynamometer
- Medical subject headings
- Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isokinetic dynamometerDevice
an isokinetic strengthening program for the quadriceps muscles. Twenty-four strengthening session will be performed using an isokinetic device. The exercise program begins with 60% of the mean peak torque, and the patient reaches this intensity by auditory biofeedback. An increasing dose program will be used in the first 5 sessions (1 set to 5 sets), and a dose of 6 sets will be applied from the sixth to twenty-fourth sessions, with the density rising from 60% to 80% of the mean peak torque according to the patient tolerance. Each set consisted of 5 repetitions of concentric (Con/Ecc) contraction in angular velocities of 30°/second and 120°/second for extensors. This program accomplished significant results in increasing the quadriceps power and strength.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | The control group will receive an isokinetic strengthening program for the quadriceps muscles. Twenty-four strengthening session will be performed using an isokinetic device. The exercise program begins with 60% of the mean peak torque, and the patient reaches this intensity by auditory biofeedback. An increasing dose program will be used in the first 5 sessions (1 set to 5 sets), and a dose of 6 sets will be applied from the sixth to twenty-fourth sessions, with the density rising from 60% to 80% of the mean peak torque according to the patient tolerance. Each set consisted of 5 repetitions of concentric (Con/Ecc) contraction in angular velocities of 30°/second and 120°/second for extensors. This program accomplished significant results in increasing quadriceps power and strength. Receives: Device: Isokinetic dynamometer |
| Study group | Experimental | * Participants in the study group will perform the same exercise parameters used in the control group but in a different manner.
* The isokinetic exercise will be done with a closed eye to improve the proprioception function. This exercise will be performed for 6 sets.
* Additional training will be performed by the application of three vibrators above and on both sides of the knee joint to improve the function of the Pacinian and Meissner corpuscles which is one of the included receptors in the sensation of the fatigue. Receives: Device: Isokinetic dynamometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG of quadriceps muscles
The electromyographical analysis of quadriceps muscle at the onset of muscle fatigue and after recovery
Measured: Two Months
Secondary outcomes (2)
The fatigue index (FI)
The fatigue index (FI) was calculated according to the following formula (Bar-Or, 1987): FI = (maximal pedal speed - minimal pedal speed) / maximal pedal speed * 100.
Measured: Two months
Rating-of-Fatigue Scale
he ROF scale consists of 11 numerical points that range from 0 to 10. There are also five descriptors and five diagrams to help the person understand the scale and make a rating.
The Rating of fatigue scale consists of 11 numerical points that range from 0 to 10. There are also five descriptors and five diagrams to help the person understand the scale and make a rating.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Apr 2021 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proprioceptive DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ayman Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayman Mohamed, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470362
- Sponsor's protocol ID
- 250982
- Status last verified
- Jul 2020
- First submitted
- 10 Jul 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beni-Suef University
- ClinicalTrials.gov ID
- NCT04470362
- Acronym / sponsor ID
- 250982
- Conditions
- Proprioceptive Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ayman MohamedUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 14 Jul 2020 (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.
Summary Muscle fatigue is a serious problem commonly occur in older ages. Muscle fatigue disturbs both daily life activities and rehabilitation tolerance in elderlies. Muscle fatigue happens due to the motor or sensory dysfunctions. The previous interventions focused mainly on the motor causes of muscle fatigue, however the important role of the sensory system in driving the motor system. It has been demonstrated that proprioceptors are mainly responsible for sensing the muscle fatigue. Objectives: This study will be conducted to investigate 1. The effect of proprioception training on reducing the occurrence of muscle fatigue in elderlies. 2. The effect of proprioceptive training on delaying the deterioration in electromyographical data from muscles of lower limbs.
Detailed description
Study protocol A single blinded randomized parallel study design will be used in this study. 40 participants will be recruited for this study aged from 65 to 90 years old. The randomization will be performed using simple envelop methods. Participants will be divided into two groups, control and study groups. The control group will receive an isokinetic strengthening program for the quadriceps muscles. Twenty-four strengthening session will be performed using an isokinetic device. The exercise program begins with 60% of the mean peak torque, and the patient reaches this intensity by auditory biofeedback. An increasing dose program will be used in the first 5 sessions (1 set to 5 sets), and a dose of 6 sets will be applied from the sixth to twenty-fourth sessions, with the density rising from 60% to 80% of the mean peak torque according to the patient tolerance. Each set consisted of 5 repetitions of concentric (Con/Ecc) contraction in angular velocities of 30°/second and 120°/second for extensors. This program accomplished significant results in increasing the quadriceps power and strength.
Participants in the study group will perform the same exercise parameters used in the control group but in a different manner. The isokinetic exercise will be done with a closed eye to improve the proprioception function. This exercise will be performed for 6 sets. We will add another set, in which the participant will be instructed that the range of motion of the knee joint will be divided into three ranges, the outer range (from 0 to 90 degrees of knee flexion), the middle range (90 degrees of flexion) and inner range (from 90 degrees to 145 degree of flexion). During this set, the isokinetic device will be stopped at a different joint angle and the participant will be asked to identify at which range the knee joint is in. This modification is directed to improve the function of muscle spindles and Golgi tendon organs.
Additional training will be performed by the application of three vibrators above and on both sides of the knee joint to improve the function of the Pacinian and Meissner corpuscles which is one of the included receptors in the sensation of the fatigue. This vibration will be set at a subsensory intensity (Stochastic theory39) and a frequency fluctuating frequency from 50 Hz to 250 Hz to train both receptors40 and it will be performed for 20 min/each session. This programs will be performed for three sessions/week for two months.
The primary outcomes measure will be the electromyographical analysis of quadriceps muscle at the onset of muscle fatigue and after recovery. The secondary outcome measures will include the Fatigue Index (FI) and the Rating-of-Fatigue Scale. These measurements at baseline, After one month, After two months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Device: Isokinetic dynamometerThe control group will receive an isokinetic strengthening program for the quadriceps muscles. Twenty-four strengthening session will be performed using an isokinetic device. The exercise program begins with 60% of the mean peak torque, and the patient reaches this intensity by auditory biofeedback. An increasing dose program will be used in the first 5 sessions (1 set to 5 sets), and a dose of 6 sets will be applied from the sixth to twenty-fourth sessions, with the density rising from 60% to 80% of the mean peak torque according to the patient tolerance. Each set consisted of 5 repetitions of concentric (Con/Ecc) contraction in angular velocities of 30°/second and 120°/second for extensors. This program accomplished significant results in increasing quadriceps power and strength. |
| Study group | Experimental | Device: Isokinetic dynamometer* Participants in the study group will perform the same exercise parameters used in the control group but in a different manner. * The isokinetic exercise will be done with a closed eye to improve the proprioception function. This exercise will be performed for 6 sets. * Additional training will be performed by the application of three vibrators above and on both sides of the knee joint to improve the function of the Pacinian and Meissner corpuscles which is one of the included receptors in the sensation of the fatigue. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Elderlies over 65 years old
Key exclusion criteria (1 listed)
- No previous history of lower extremity trauma, serious metabolic, neurological, muscular, inflammatory or cardiovascular diseases
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 |
|---|---|---|
| Isokinetic dynamometeran isokinetic strengthening program for the quadriceps muscles. Twenty-four strengthening session will be performed using an isokinetic device. The exercise program begins with 60% of the mean peak torque, and the patient reaches this intensity by auditory biofeedback. An increasing dose program will be used in the first 5 sessions (1 set to 5 sets), and a dose of 6 sets will be applied from the sixth to twenty-fourth sessions, with the density rising from 60% to 80% of the mean peak torque according to the patient tolerance. Each set consisted of 5 repetitions of concentric (Con/Ecc) contraction in angular velocities of 30°/second and 120°/second for extensors. This program accomplished significant results in increasing the quadriceps power and strength. | Device | Control group, Study group |
Primary outcome
EMG of quadriceps muscles
Time frame: Two Months
The electromyographical analysis of quadriceps muscle at the onset of muscle fatigue and after recovery
2 secondary outcomes
The fatigue index (FI)
Time frame: Two months
Rating-of-Fatigue Scale
Time frame: Two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isokinetic dynamometer in people with Proprioceptive Disorders, run by Ayman Mohamed 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Jul 2020. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EMG of quadriceps muscles (time frame: Two 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 14 Jul 2020.