NCT06646510

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

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

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

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2025

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

October 15, 2024

Last Update Submit

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 COMPARATOR

traditional treatment of hand tremors

Other: traditional exercises

study group

EXPERIMENTAL

traditional treatment in addition to sensory electrical stimulation

Other: traditional exercisesOther: 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

control groupstudy group

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

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Outpatient clinics, Faculty of Physical Therapy, Cairo University

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

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

Locations