Effect of Sensory Electrical Stimulation on Resting Tremors in Patients with Parkinson's Disease
1 other identifier
interventional
30
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable parkinson-disease
Started Aug 2024
Shorter than P25 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2024
CompletedFirst Submitted
Initial submission to the registry
October 15, 2024
CompletedFirst Posted
Study publicly available on registry
October 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2025
CompletedOctober 18, 2024
October 1, 2024
5 months
October 15, 2024
October 17, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
3 weeks
Study Arms (2)
control group
ACTIVE COMPARATORtraditional treatment of hand tremors
study group
EXPERIMENTALtraditional treatment in addition to sensory electrical stimulation
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Outpatient clinics, Faculty of Physical Therapy, Cairo University
Giza, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 15, 2024
First Posted
October 17, 2024
Study Start
August 1, 2024
Primary Completion
December 30, 2024
Study Completion
January 5, 2025
Last Updated
October 18, 2024
Record last verified: 2024-10