- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07610031
Trunk Control Exercises and Mirror Therapy on Balance and Posture in Parkinson's Disease
Effects of Trunk Control Exercises and Mirror Therapy on Balance and Posture in Patients With Parkinson's Disease
Parkinson's disease (PD) is movement disorder of the nervous system that worsens over time. As nerve cells (neurons) in parts of the brain weaken or are damaged or die, people may begin to notice problems with movement, tremor, stiffness in the limbs or the trunk of the body, or impaired balance. As these symptoms become more obvious, people may have difficulty walking, talking, or completing other simple tasks. Not everyone with one or more of these symptoms has PD, as the symptoms appear in other diseases as well.
Both non-modifiable (age, gender) and modifiable risk factors such as occupation, exposure to pesticides, and depression have an association with PD. Several studies have suggested that Parkinson disease is more common in men. The MT mechanism is based on the concept of visual illusion. The movement of the non-paretic part in front of the mirror (reflective side) is perceived as that of the paretic body part (hidden beside the mirror). MT allows an individual to have an experience of normal movement, even for the severely paralyzed limb. In addition, wherever other rehabilitation methods fail to induce normal movements without any compensation, MT may act as a foundation step for further motor therapy. The perception of movement illusion, a neuropsychological phenomenon may induce neural activation of the lesioned brain and enhance associated motor recovery. Therefore the aim of this study is to compare the effects of truck control exercise program and mirror therapy on balance and postural instability in patients with Parkinson's disease.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Parkinson's disease (PD) is movement disorder of the nervous system that worsens over time. As nerve cells (neurons) in parts of the brain weaken or are damaged or die, people may begin to notice problems with movement, tremor, stiffness in the limbs or the trunk of the body, or impaired balance. As these symptoms become more obvious, people may have difficulty walking, talking, or completing other simple tasks. Not everyone with one or more of these symptoms has PD, as the symptoms appear in other diseases as well. Both non-modifiable (age, gender) and modifiable risk factors such as occupation, exposure to pesticides, and depression have an association with PD. Several studies have suggested that Parkinson disease is more common in men. The MT mechanism is based on the concept of visual illusion. The movement of the non-paretic part in front of the mirror (reflective side) is perceived as that of the paretic body part (hidden beside the mirror). MT allows an individual to have an experience of normal movement, even for the severely paralyzed limb. In addition, wherever other rehabilitation methods fail to induce normal movements without any compensation, MT may act as a foundation step for further motor therapy. The perception of movement illusion, a neuropsychological phenomenon may induce neural activation of the lesioned brain and enhance associated motor recovery. Therefore the aim of this study is to compare the effects of truck control exercise program and mirror therapy on balance and postural instability in patients with Parkinson's disease.
Screening: Patients will be screened to meet inclusion criteria. The consent form will be taken from patients then patients will be randomly allocated into two groups (28 in each group). Patients fulfilling the inclusion criteria will be randomly divided into experimental and control groups using the computer software. The study will be single-blinded. The assessor will be unaware of the treatment given to both groups. Data will be collected at baseline and then at the end of the sixth week. Before applying intervention, Berg Balance scale will be used to measure level of balance and goniometer will be used to measure two-dimensional angular deviations between the pelvis and the upper part of the trunk.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Ishaq Ahmed, PHD
- Numer telefonu: 0334 4066 463
- E-mail: ishaq.ahmed@uipt.uol.edu.pk
Kopia zapasowa kontaktu do badania
- Nazwa: Ashfaq Ahmad, PHD
- Numer telefonu: 03009449192
- E-mail: ashfaq.ahmad@uipt.uol.edu.pk
Lokalizacje studiów
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Rekrutacyjny
- Nimra Nadeem
-
Kontakt:
- Hafiza Sana Ashraf, MS-MSK
- Numer telefonu: 03224866794
- E-mail: sana.ashraf@uipt.uol.edu.pk
-
Kontakt:
- Muhammad Asim Arif, MS-MSK, PhD*
- Numer telefonu: 03216597727
- E-mail: asim.arif@uol.edu.pk
-
Główny śledczy:
- Nimra Nadeem, MS-MSK
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
• 50-70 age(Bomasang-Layno et al., 2015)
- Both genders (Bomasang-Layno et al., 2015)
- Patient with grade 1,2,3 Parkinsonism (according to Hoehn and Yahr scale)
- Patient taking fixed dose of medicines
- No cognitive impairment (according to Mini-Mental scale 24-30 scoring) (Capecci et al., 2014)
- The patient was able to get out of chairs and beds without assistance (Hoffmann et al., 2016).
- Individuals without significant dyskinesias or "on-off" periods.(Lötzke et al., 2015)
Exclusion Criteria:
• Patient having any recent episode of epilepsy(Bomasang-Layno et al., 2015)
- Patient has had any recent trauma. (Hong et al., 2009)
- Individuals free from chronic diseases such as unstable cardiovascular disease that could compromise their safety during training or testing (Hoffmann et al., 2016).
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Trunk control exercise
The participants will complete balance exercises which targeted their feedforward along with feedback postural reflexes.
The exercise program will include three different groups of tasks: self-destabilizing movements such as rolling on the toes and bouncing a ball while walking as well as external destabilization tasks like balancing on foam surfaces and therapist-performed perturbations and coordinated arm movements during walking.
The patients will undergo ten specific movements per session and medical staff raised the exercise difficulty level as they made improvement.
The principal investigator will provide verbal instruction together with physical help if required.
|
The participants will complete balance exercises which targeted their feedforward along with feedback postural reflexes.
The exercise program will include three different groups of tasks: self-destabilizing movements such as rolling on the toes and bouncing a ball while walking as well as external destabilization tasks like balancing on foam surfaces and therapist-performed perturbations and coordinated arm movements during walking.
The patients will undergo ten specific movements per session and medical staff raised the exercise difficulty level as they made improvement.
The principal investigator will provide verbal instruction together with physical help if required.
In this, each patient will be instructed to keep the affected limb in static position.
The limb will be in the position of hip 90°, knee 90°, and ankle 90° for the short-sitting posture and in the position of hip 90°, knee 0°, and ankle neutral in the long-sitting posture.
The position of the limb was ensured from time to time.
The repetition will be modulated to complete the maximum time of each session.
Weight bearing in standing (extended knee) 2-3 minutes, Weight bearing in standing on inclined wedge 2-3 minutes.
Movements using associated reactions 10 repetitions, Knee flexion control in prone position 10 repetitions, Active-assistive movement using activities (medicinal ball, rocker board, pedocycle, jogger) for hip (flexion), knee (flexion-extension) and ankle (ankle dorsi flexion-plantar flexion) in sitting position 10 repetitions for each.
|
|
Eksperymentalny: Mirror therapy
In this, each patient will be instructed to keep the affected limb in static position.
The limb will be in the position of hip 90°, knee 90°, and ankle 90° for the short-sitting posture and in the position of hip 90°, knee 0°, and ankle neutral in the long-sitting posture.
The position of the limb was ensured from time to time.
The repetition will be modulated to complete the maximum time of each session.
Weight bearing in standing (extended knee) 2-3 minutes, Weight bearing in standing on inclined wedge 2-3 minutes.
Movements using associated reactions 10 repetitions, Knee flexion control in prone position 10 repetitions, Active-assistive movement using activities (medicinal ball, rocker board, pedocycle, jogger) for hip (flexion), knee (flexion-extension) and ankle (ankle dorsi flexion-plantar flexion) in sitting position 10 repetitions for each.
|
The participants will complete balance exercises which targeted their feedforward along with feedback postural reflexes.
The exercise program will include three different groups of tasks: self-destabilizing movements such as rolling on the toes and bouncing a ball while walking as well as external destabilization tasks like balancing on foam surfaces and therapist-performed perturbations and coordinated arm movements during walking.
The patients will undergo ten specific movements per session and medical staff raised the exercise difficulty level as they made improvement.
The principal investigator will provide verbal instruction together with physical help if required.
In this, each patient will be instructed to keep the affected limb in static position.
The limb will be in the position of hip 90°, knee 90°, and ankle 90° for the short-sitting posture and in the position of hip 90°, knee 0°, and ankle neutral in the long-sitting posture.
The position of the limb was ensured from time to time.
The repetition will be modulated to complete the maximum time of each session.
Weight bearing in standing (extended knee) 2-3 minutes, Weight bearing in standing on inclined wedge 2-3 minutes.
Movements using associated reactions 10 repetitions, Knee flexion control in prone position 10 repetitions, Active-assistive movement using activities (medicinal ball, rocker board, pedocycle, jogger) for hip (flexion), knee (flexion-extension) and ankle (ankle dorsi flexion-plantar flexion) in sitting position 10 repetitions for each.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Berg Balance Scale:
Ramy czasowe: 12 weeks
|
Using a series of pre-established exercises, the Berg Balance Scale (BBS) evaluates a patient's objective ability-or lack thereof-to maintain balance (Lima et al., 2018).
The fourteen things on the list are assessed on a five-point ordinal scale, with 0 being the lowest degree of function and 4 the greatest level.
Completing the list takes approximately twenty minutes.
It excludes the gait analysis.
(Louie & Eng, 2018).
|
12 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS-PG):
Ramy czasowe: 12 weeks
|
The Unified Parkinson's Disease Rating Scale (UPDRS-PG) posture and gait sub-scores were used to assess postural stability and gait problems.
It is divided into four pieces.
Each part has many points: zero for normal or no problems, one for minor problems, two for moderate problems, three for major problems, and four for severe problems.(Shen
& Mak, 2015).
|
12 weeks
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Nimra Nadeem, MS (NMPT), University of Lahore
- Główny śledczy: Hafiza Sana Ashraf, MS-MSK, University of Lahore
Publikacje i pomocne linki
Publikacje ogólne
- Lopez-Liria R, Vega-Tirado S, Valverde-Martinez MA, Calvache-Mateo A, Martinez-Martinez AM, Rocamora-Perez P. Efficacy of Specific Trunk Exercises in the Balance Dysfunction of Patients with Parkinson's Disease: A Systematic Review and Meta-Analysis. Sensors (Basel). 2023 Feb 6;23(4):1817. doi: 10.3390/s23041817.
- Hubble RP, Silburn PA, Naughton GA, Cole MH. Trunk Exercises Improve Balance in Parkinson Disease: A Phase II Randomized Controlled Trial. J Neurol Phys Ther. 2019 Apr;43(2):96-105. doi: 10.1097/NPT.0000000000000258.
- Aarsland D, Batzu L, Halliday GM, Geurtsen GJ, Ballard C, Ray Chaudhuri K, Weintraub D. Parkinson disease-associated cognitive impairment. Nat Rev Dis Primers. 2021 Jul 1;7(1):47. doi: 10.1038/s41572-021-00280-3.
- Bonassi G, Pelosin E, Ogliastro C, Cerulli C, Abbruzzese G, Avanzino L. Mirror Visual Feedback to Improve Bradykinesia in Parkinson's Disease. Neural Plast. 2016;2016:8764238. doi: 10.1155/2016/8764238. Epub 2016 Aug 1.
- Gandolfi M, Tinazzi M, Magrinelli F, Busselli G, Dimitrova E, Polo N, Manganotti P, Fasano A, Smania N, Geroin C. Four-week trunk-specific exercise program decreases forward trunk flexion in Parkinson's disease: A single-blinded, randomized controlled trial. Parkinsonism Relat Disord. 2019 Jul;64:268-274. doi: 10.1016/j.parkreldis.2019.05.006. Epub 2019 May 3.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- REC-UOL-/343/08/24
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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