Parkinson DiseaseNCT06646510
Effect of Sensory Electrical Stimulation on Resting Tremors in Patients with Parkinson's Disease
A study testing traditional exercises and sensory electrical stimulation in people with Parkinson Disease, run by Cairo University at 1 site in Egypt.
Trial summary
Parkinson's disease is one of the most prevalent motor disorders in the world . The disease is progressive and has no known treatment. In addition to a number of psychological and autonomic issues, the disease also cause movement abnormalities which are the most challenging problem because management is still limited… Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- traditional exercises and sensory electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 5 Jan 2025
- 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 45 and 60
- Diagnosed with idiopathic Parkinson's disease with Magnetic resonance imaging of the brain
- All the patients will have mild to moderate symptoms based on (the Unified Parkinson's Disease Rating Scale UPDRS) ≥ 3
- Static tremors have been present at the hand and wrist
- Absence of other disorders that cause similar symptoms like dystonia
Who cannot join
- History of hand trauma causes stiffness
- Presence of other neurological problems interferes with diagnosis as hemiplegic stroke
- Secondary parkinsonism (drug-induced or vascular ) which has very low tremor magnitude which can not be detected The patient has a severe visual problem that does not allow following the instructions.
- The patient educational level does not allow for following the instructions.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinics, Faculty of Physical Therapy, Cairo University
Giza
mohamed yassin, +202 37617691, Info@pt.cu.edu.eg
Mohamed Yassin, MSc
About this study
Parkinson's disease is one of the most prevalent motor disorders in the world . The disease is progressive and has no known treatment. In addition to a number of psychological and autonomic issues, the disease also cause movement abnormalities which are the most challenging problem because management is still limited by medication or traditional physiotherapy the most effective way to treat symptoms is through an interprofessional new modalities as sensory stimulation , this study will be the first of its type to measure the effect of sensory stimulation on static tremors. Also, this study is the first of its type to make a continues treatment protocol for patient with static tremors.
SO the purpose of these study will To investigate the effect of sensory electrical stimulation on resting tremors in Parkinson's patients.
- Conditions
- Parkinson Disease
- Being tested
- traditional exercises, sensory electrical stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional exercisesOther
strengthening exercise for the shoulder muscles( shoulder extensors, shoulder retractors from prone position and shoulder external rotation exercise for 3 sets 10 repetition , weight bearing exercise on the hand from quadruped position and sitting position and strengthening exercise on the intrinsic muscles of the hand
sensory electrical stimulationOther
The stimulated muscles included the flexor carpi radialis (FCR), extensor carpi radialis (ECR), and flexor carpi ulnaris (FCU). Rectangular surface electrodes (Ag/AgCl; 50mm _ 50mm size) were attached on the motor point of each muscle, i.e., at four fingerbreadths from biceps tendon of FCR, at two fingerbreadths distal from lateral epicondyle for the ECR, at two fingerbreadths volar to ulna at the junction of the upper and middle thirds of the forearm for FCU.14 Portable stimulators will use with the following stimulation settings: constant current (0.2 mA step), 100 Hz stimulation frequency, biphasic pulse, and 300 _s pulsewidth.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | traditional treatment of hand tremors Receives: Other: traditional exercises |
| study group | Experimental | traditional treatment in addition to sensory electrical stimulation Receives: Other: traditional exercises; Other: sensory electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
triaxial gyrosensor (accelerator)
Three-dimensional angular motion will measured at the index finger of the more affected hand, by using triaxial gyrosensor (STM32L151, STMicroelectronics, ). The gyrosensor will embedded in an elastic band and attached on the dorsum of proximal phalanx
Measured: 3 weeks
Fahn-tolosa- marin clinical rating scale
Fahn_tolosa_marin clinical rating scale( FTM) is avalid scale for asses hand tremor, it consist of two items related to the hand , 1_trmors 2_hand writing The score is form 0 to 4 , 0 mean no tremors , 4 means severe tremors
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Aug 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion5 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Yassen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646510
- Sponsor's protocol ID
- P.T.REC/012/005124
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 18 Oct 2024
- 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 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sensory Electrical Stimulation on Resting Tremors in Patients with Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06646510
- Acronym / sponsor ID
- P.T.REC/012/005124
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 5 Jan 2025 (estimated)
- First posted
- 17 Oct 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.
Parkinson's disease is one of the most prevalent motor disorders in the world . The disease is progressive and has no known treatment. In addition to a number of psychological and autonomic issues, the disease also cause movement abnormalities which are the most challenging problem because management is still limited by medication or traditional physiotherapy the most effective way to treat symptoms is through an interprofessional new modalities as sensory stimulation , this study will be the first of its type to measure the effect of sensory stimulation on static tremors. Also, this study is the first of its type to make a continues treatment protocol for patient with static tremors.
SO the purpose of these study will To investigate the effect of sensory electrical stimulation on resting tremors in Parkinson's patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: traditional exercisestraditional treatment of hand tremors |
| study group | Experimental | Other: traditional exercises, Other: sensory electrical stimulationtraditional treatment in addition to sensory electrical stimulation |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 45 and 60
- Diagnosed with idiopathic Parkinson's disease with Magnetic resonance imaging of the brain
- All the patients will have mild to moderate symptoms based on (the Unified Parkinson's Disease Rating Scale UPDRS) ≥ 3
- Static tremors have been present at the hand and wrist
- Absence of other disorders that cause similar symptoms like dystonia
Key exclusion criteria (4 listed)
- History of hand trauma causes stiffness
- Presence of other neurological problems interferes with diagnosis as hemiplegic stroke
- Secondary parkinsonism (drug-induced or vascular ) which has very low tremor magnitude which can not be detected The patient has a severe visual problem that does not allow following the instructions.
- The patient educational level does not allow for following the instructions.
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 |
|---|---|---|
| traditional exercisesstrengthening exercise for the shoulder muscles( shoulder extensors, shoulder retractors from prone position and shoulder external rotation exercise for 3 sets 10 repetition , weight bearing exercise on the hand from quadruped position and sitting position and strengthening exercise on the intrinsic muscles of the hand | Other | control group, study group |
| sensory electrical stimulationThe stimulated muscles included the flexor carpi radialis (FCR), extensor carpi radialis (ECR), and flexor carpi ulnaris (FCU). Rectangular surface electrodes (Ag/AgCl; 50mm _ 50mm size) were attached on the motor point of each muscle, i.e., at four fingerbreadths from biceps tendon of FCR, at two fingerbreadths distal from lateral epicondyle for the ECR, at two fingerbreadths volar to ulna at the junction of the upper and middle thirds of the forearm for FCU.14 Portable stimulators will use with the following stimulation settings: constant current (0.2 mA step), 100 Hz stimulation frequency, biphasic pulse, and 300 _s pulsewidth. | Other | study group |
Primary outcome
triaxial gyrosensor (accelerator)
Time frame: 3 weeks
Three-dimensional angular motion will measured at the index finger of the more affected hand, by using triaxial gyrosensor (STM32L151, STMicroelectronics, ). The gyrosensor will embedded in an elastic band and attached on the dorsum of proximal phalanx
Fahn-tolosa- marin clinical rating scale
Time frame: 3 weeks
Fahn_tolosa_marin clinical rating scale( FTM) is avalid scale for asses hand tremor, it consist of two items related to the hand , 1_trmors 2_hand writing The score is form 0 to 4 , 0 mean no tremors , 4 means severe tremors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- 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.
Outpatient clinics, Faculty of Physical Therapy, Cairo University
Giza, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional exercises and sensory electrical stimulation in people with Parkinson Disease, run by Cairo University 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 5 inclusion and 4 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 18 Oct 2024. 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?
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?
triaxial gyrosensor (accelerator) (time frame: 3 weeks). The study lists 2 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 18 Oct 2024.