Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05900934 |
| Other study ID # |
KA-22060 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2023 |
| Est. completion date |
September 15, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Hacettepe University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this study, the investigators plan to have Parkinson's patients perform exercises
according to the task-oriented training method. Since recent studies have suggested that
task-oriented training should be organized as a series of workstations that allow for more
intensive practice, each of them has a program content implemented in the form of a station.
The program will be implemented in 11 different stations with 3 minutes and a 1-minute break
at each station, 3 days a week for 8 weeks under the supervision and guidance of a
physiotherapist. The task-oriented training program will be carried out by applying the
above-mentioned exercises in the form of stations sequentially within a certain period of
time. For all exercises, the intensity perceived by the individuals will be ensured to be
12-15 points of perceived exertion according to the Borg Perceived Exertion Scale. In this
way, the exercise program can be easily individualized according to the participant's pain,
complaints, and functional status. In the study, after the task-oriented approach, foam
roller application and myofascial release will be applied at the end of each session.
Foam roller application; C7-T1 and posterior neck region, thoracic spine, lumbar spine, and
right and left sides of the thoracolumbar spine will be applied with a foam roller, which is
a myofascial release device, in each session. Each application area will be applied in 3 sets
of 60 seconds of application and 30 seconds of rest. The intensity of the pressure for the
intensity of the application will be subjectively controlled with a target numeric rating
scale rating of 7/10 (0 represents no discomfort and 10 represents maximum discomfort). In
the sham group, similar to the literature, the intensity of the application will be applied
in accordance with the 0/10 numeric rating scale, at the same application sites, for the same
duration and the same rest intervals.
Within the scope of this study, participants gait, balance, rotation time, range of motion,
level of achievement of the treatment goal, quality of life and trunk impairment will be
evaluated at the beginning of the study and at the end of 8 weeks.
Description:
Participants who meet the inclusion criteria will be randomly divided into 2 groups as
'PH-Myofascial Release Group' and 'PH-Sham Myofascial Release Group' as the control arm by
closed envelope method. In this randomized controlled study, the noninvasive application will
be performed with Foam rollers for the same duration, same muscle area, same set intervals
and same number of sets in both groups. The intensity of the applications will be different
for the research arm (PH-Myofascial Relaxation Group) for the C7-T1 spine and posterior neck
region of the body, thoracic spine, lumbar spine, thoracolumbar spine right and left sides of
the body according to the Numeric Pain Scale 7/10 and for the control arm (PH- Sham
Myofascial Relaxation Group) 0/10 intensity on the same scale will be applied as applied in
the literature. After the exercise application called task-oriented training protocol is
applied to both groups, foam roller application time will be applied to each application area
as 3 sets of 60 s applications and 30 s rest. The application will be performed 3 days a week
for 8 weeks under the supervision of a physiotherapist. Task-oriented training; It has a
program content consisting of coming from sitting to standing, standing, get up and walk
exercise, walking exercise on the inclined ground, step exercise, slalom exercise, stair
exercise, touching different points in the mirror exercise, reaching exercise, boxing
exercise, balance exercise on moving ground, mat exercise, writing, eating exercise, each of
which is applied in the form of a station. Since the limitation in the trunk in Parkinson's
disease may also be caused by non-neural structures, it is curious to evaluate the effects of
myofascial release. The effects of myofascial release when applied in combination with a
task-oriented exercise approach compared to the sham application have not yet been shown on
basic motor parameters such as balance and gait in neurological diseases. Based on these
premises, the aim of the study was to evaluate the effects of foam roller application in
patients with Parkinson's disease when applied in combination with a rehabilitation program.
