Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000120370
Ethics application status
Approved
Date submitted
8/12/2016
Date registered
23/01/2017
Date last updated
30/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Balance disorders in patients with idiopathic epilepsy
Scientific title
Effect of physiotherapy using a stabilometric platform on mean Electroencephalography (EEG) readings in patients with idiopathic epilepsy
Secondary ID [1] 290711 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
idiopathic epilepsy 301271 0
balance disorders 301272 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301030 301030 0 0
Physiotherapy
Neurological 301031 301031 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be tested 3 times (at first visit, after 1 month at second visit and after 2 month at third visit) using EEG (32 channels), MMSE, SF-36 test and stabilometric platform (modified sensory organisation test and Posturography). The study group also between the second and third visit will undergo physiotherapy oriented imbalance (3 times a week during 1 month, each session 30 min.) by a qualified physiotherapist on stabilometric platform. Patients will train postural stability 15 minutes on hard surfaces and 15 minutes on foam with eyes closed and open. Patients will maintain the position of the equally load on both lower limbs. The therapy will be conducted face to face, individually on the balance platform located in the John Paul II Hospital in Krakow on the neurological department. The patient on the stabilometric platform will be coached postural stability on hard or soft ground, eyes closed or open, depending on the results obtained in the study during the second visitl clinic during the visit. In addition, during the visit it will be executed test MMS verifying patients with cognitive dysfunctions. Research on the stabilometric platform will be made with the use of medical equipment available on the neurological department in hospital
Intervention code [1] 296603 0
Rehabilitation
Intervention code [2] 296604 0
Diagnosis / Prognosis
Comparator / control treatment
Patients will be tested 3 times every month. Patients between first and second visit are without intervention (just normal daily living activities). Results from this period will be the control group for the results after intervention. Patients between the second and third examination will undergo physiotherapy. The patients results after month without intervention will provide a control group for phsyiotherapy.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300451 0
mean change in EEG
Timepoint [1] 300451 0
baseline, 1 month without intervention, 2 month after phsyiotherapy
Primary outcome [2] 300452 0
mean COP in posturgraphy and modified sensory organisation test
Timepoint [2] 300452 0
baseline, 1 month without intervention, 2 month after phsyiotherapy
Primary outcome [3] 300453 0
mean SF-36 score
Timepoint [3] 300453 0
baseline, 1 month without intervention, 2 month after phsyiotherapy
Secondary outcome [1] 330010 0
mean MMSE score
Timepoint [1] 330010 0
baseline, 1 month without intervention, 2 month after phsyiotherapy

Eligibility
Key inclusion criteria
Inclusion criteria:
- Diagnosed idiopathic epilepsy
- Stable, optimal drug therapy for at least three months prior to the study
- MMSE score higher than 24 points,
- Properly executed test clock
- The age of 18-30 years
- Written consent of the patient
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
exclusion criteria
- Diagnosed with drug-resistant epilepsy
- Benzodiazepines use in the treatment and / or psychotropic drugs
- Orthopedic disorders and / or neurological disorders resulting in damage to the musculoskeletal system
- The presence of other acute and / or chronic diseases which have a significant impact on the health of the patient, eg. Myocardial infarction, cancer, COPD

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/01/2017
Date of last participant enrolment
Anticipated
Actual
11/04/2017
Date of last data collection
Anticipated
Actual
3/10/2017
Sample size
Target
10
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 8470 0
Poland
State/province [1] 8470 0
Malopolska

Funding & Sponsors
Funding source category [1] 295140 0
Hospital
Name [1] 295140 0
John Paul II Hospital
Country [1] 295140 0
Poland
Primary sponsor type
Hospital
Name
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Address
ul. Pradnicka 80
31- 202 Cracow
Country
Poland
Secondary sponsor category [1] 293960 0
None
Name [1] 293960 0
Address [1] 293960 0
Country [1] 293960 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296487 0
Bioethics Committee at the regional medical assosiation in Krakow
Ethics committee address [1] 296487 0
ul. Krupnicza 11a
31-123 Cracow
Ethics committee country [1] 296487 0
Poland
Date submitted for ethics approval [1] 296487 0
13/09/2016
Approval date [1] 296487 0
19/09/2016
Ethics approval number [1] 296487 0
156/KBL/OIL/2016

Summary
Brief summary
Summation:
- As a result of seizures reported to affect the functioning of the central nervous system, which is responsible for maintaining balance. One of the functional components of locomotion is a balance which affects the movement of patients and thereby quality of life
- There are no standards of conduct in physiotherapy patients with idiopathic epilepsy
- Pilot study is the first step in the preparation of the December call for the application to the National Science Centre
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71038 0
Dr Elzbieta Szczygiel-Pilut
Address 71038 0
John Paul II Hospital
ul. Pradnicka 80
31- 202 Cracow
Country 71038 0
Poland
Phone 71038 0
+48506390904
Fax 71038 0
Email 71038 0
[email protected]
Contact person for public queries
Name 71039 0
Dr Magdalena Filip
Address 71039 0
The University of Physical Education
31-571 Cracow Al. Jana Pawla II 78
Country 71039 0
Poland
Phone 71039 0
+48881304466
Fax 71039 0
Email 71039 0
[email protected]
Contact person for scientific queries
Name 71040 0
Dr Magdalena Filip
Address 71040 0
The University of Physical Education
31-571 Cracow Al. Jana Pawla II 78
Country 71040 0
Poland
Phone 71040 0
+48881304466
Fax 71040 0
Email 71040 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.