Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06215898 |
| Other study ID # |
IZBU-"PEKMEZCIZEYNEPULKU"-0001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2023 |
| Est. completion date |
October 15, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Izmir Bakircay University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Parkinson's disease is a progressive, degenerative neurological disease manifested by motor
and non-motor symptoms. Treatment for Parkinson's disease is symptom-oriented. Treatment
options include medical treatment and surgical treatment, as well as physiotherapy and
rehabilitation interventions. The LSVT-BIG protocol, a physiotherapy and rehabilitation
intervention, aims to overcome the insufficient speed-amplitude regulation that leads to low
scaling of motion amplitude at any speed in Parkinson's disease. The protocol is applied for
four weeks, four days a week, and each session is one hour. Each treatment session consists
of four parts: maximal daily exercises, functional component tasks, hierarchy tasks, and
grand walking. Telerehabilitation is a system established for the online delivery of
different rehabilitation services via telecommunication, and it has been reported that the
LSVT-BIG protocol is a viable method with image-based video conferencing systems.
This study is a randomized controlled trial designed to examine the effect of the LSVT-BIG
protocol on balance, gait, fatigue and quality of life. In this direction, thirty-four
Parkinson's patients will be divided into two groups by randomization method after a
preliminary evaluation including balance, gait, fatigue and quality of life variables. While
the telerehabilitation-based LSVT-BIG protocol was applied to the experimental group for four
weeks, no physiotherapy and rehabilitation interventions would be applied to the control
group in addition to the medical treatment for the same period. At the end of four weeks,
both groups will be evaluated again, including balance, gait, fatigue and quality of life
variables. Evaluation data will be collected from patients through face-to-face evaluation
methods and prepared questionnaires and scales. The obtained data will be evaluated using
appropriate statistical methods using the SPSS statistical program.
Description:
Parkinson's disease is a progressive, degenerative neurological disease manifested by motor
and non-motor symptoms. Motor symptoms include resting tremor, bradykinesia, postural
instability, rigidity, postural deformities, and gait disturbances. Non-motor symptoms
include cognition and behavioral disorders, autonomic dysfunctions, sleep and sensory
disturbances. These symptoms reduce the quality of life of patients and prevent participation
in activities of daily living. Treatment for Parkinson's disease is symptom-oriented. These
treatment options include medical treatment and surgical treatment, as well as physiotherapy
and rehabilitation interventions.
Physiotherapy and rehabilitation interventions aim to maximize functional ability, minimize
secondary complications, control unwanted side effects of medical treatment and possible
motor fluctuations. For this purpose, intervention methods such as aerobic and strengthening
exercises, balance and gait training, motor learning and movement strategies and the LSVT-BIG
protocol are used in physiotherapy and rehabilitation programs.
LSVT-BIG protocol; derived from the Lee Silverman Voice Treatment protocol developed to
improve hypophonia in Parkinson's patients, it is a treatment protocol that includes large
amplitude body movements to increase both the speed and amplitude of functional movements.
The goal of this protocol is to overcome the insufficient speed-amplitude regulation that
leads to low scaling of the amplitude of motion at any given speed. Continuous feedback on
motor performance and motion perception training in the protocol is used to offset the
reduced gain in motor activities as a result of impaired sensorimotor processing. The
protocol is applied for four weeks, four days a week, and each session is one hour. Each
treatment session consists of four parts: maximal daily exercises, functional component
tasks, hierarchy tasks, and big walking. In the study of Fishel et al., the LSVT-BIG protocol
was applied to patients with intermediate Parkinson's disease. According to the results of
this study, the LSVT-BIG protocol has a positive effect on balance, fall and walking
variables. The study by Farley et al. showed that the LSVT-BIG protocol improved gait. It has
been reported that improvement is higher especially in Hoehn Yahr stage 1 Parkinson's
patients. The study by Sundaran et al suggests that balance ability in patients with
Parkinson's is improved by the LSVT-BIG protocol, as assessed using the Berg Balance Scale.
Telerehabilitation is a system established for the remote delivery of different
rehabilitation services via telecommunication. Online access provides advantages in terms of
distance, time and cost. By taking the rehabilitation service beyond the hospital process, it
allows patients to be treated in a comfortable and familiar environment. Intensive exercise
programs such as the LSVT-BIG protocol impose a significant time and economic burden on
patients, and there are limitations on access to the clinical setting and the practical
applicability of the treatment. It is thought that these limitations can be eliminated by
using the telerehabilitation method in practice. It has been reported that the LSVT-BIG
protocol with telerehabilitation is a viable method with image-based video conferencing
systems. The study by Fırat et al. showed that the LSVT-BIG protocol applied on the basis of
telerehabilitation in Parkinson's patients gave positive results on quality of life, motor
and non-motor symptoms. However, this study has some limitations such as the absence of a
control group, not questioning patient satisfaction, and a small number of participants.
It is important to examine the effects of the LSVT-BIG protocol, which has been encountered
in rare studies in the literature, on the motor symptoms of Parkinson's disease, since it is
a current treatment approach. Few of these rare studies have used the telerehabilitation
method despite the advantages it provides. In this direction, this study was planned to
examine the effect of LSVT-BIG protocol applied on the basis of telerehabilitation on
balance, gait, fatigue and quality of life in Parkinson's patients.
Thirty-four Parkinson's patients will be included in the study. After the first evaluation,
the patients included in the study will be divided into two groups, defined as the
experimental and control groups, by randomization method. The telerehabilitation-based
LSVT-BIG protocol will be applied to the experimental group for four weeks, four times a week
and each session for one hour, accompanied by a physiotherapist and with one-on-one
participation. The control group will not be included in any physiotherapy and rehabilitation
practices in addition to their basic medical treatments during this period. At the end of
four weeks, a final evaluation will be made for both groups. Evaluation data will be
collected from patients through face-to-face evaluation methods, questionnaires and scales.
Demographic characteristics of the patients (gender, age, height, body weight, body mass
index, duration of the disease, dominant side, occupation, marital status, history, family
history and medications used), Hoehn Yahr Stage and UPDRS Score will be recorded.
Activity-Specific Balance Confidence Scale and Berg Balance Scale will be used for balance
assessment. In addition, one-leg standing test will be applied for the evaluation of static
balance and the four-step square test will be applied for the evaluation of dynamic balance.
For gait assessment, Dynamic Gait Index and Figure of 8 Walk Test will be applied.
Parkinson's Fatigue Scale-16 will be used for fatigue assessment and Parkinson's Disease
Questionnaire-8 will be used for quality of life assessment. Telehealth Satisfaction
Questionnaire will be applied in order to evaluate the satisfaction of the patient with the
physiotherapy and rehabilitation approach applied to the experimental group.
The data obtained will be analyzed using the "Statistical Package for Social Sciences (SPSS)"
statistical program.
