UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042722 |
|---|---|
| Receipt number | R000048762 |
| Scientific Title | Effects of therapeutic exercise focused on instruction of ankle joint movement on retropulsion in patients with Parkinson's disease: a pilot randomized controlled trial |
| Date of disclosure of the study information | 2020/12/11 |
| Last modified on | 2022/06/13 23:01:37 |
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Basic information
Public title
Effects of therapeutic exercise focused on instruction of ankle joint movement on retropulsion in patients with Parkinson's disease: a pilot randomized controlled trial
Acronym
Effects of therapeutic exercise focused on instruction of ankle joint movement on retropulsion in patients with Parkinson's disease: a pilot randomized controlled trial
Scientific Title
Effects of therapeutic exercise focused on instruction of ankle joint movement on retropulsion in patients with Parkinson's disease: a pilot randomized controlled trial
Scientific Title:Acronym
Effects of therapeutic exercise focused on instruction of ankle joint movement on retropulsion in patients with Parkinson's disease: a pilot randomized controlled trial
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of therapeutic exercise focused on instruction of ankle joint movement on retropulsion in patients with Parkinson's disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary efficacy outcome was the intergroup difference in the change in the MDS-UPDRS part III score from baseline to week 1 and week 2.
Key secondary outcomes
The secondary outcomes included timed up and go (TUG), walking speed (assessed by a 10-m walk), and performance in activities of daily living (ADL) as measured by the Barthel Index.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
<The experimental intervention group (INSTR)>
The INSTR received a two-week therapeutic exercise program involving repeated backward pulls on the shoulders with instructions to land on the toes as a response.
The daily sessions lasted 40 min and consisted of 25 min of warm-up (1) followed by 15 min of therapeutic exercise (2). Weekends were excluded, so the therapeutic exercise was performed five times a week for 10 days in an ON medication stat.
(1) Warm-up included current physical therapy such as aerobic exercise, stretching, and high-amplitude movements, as well as active workouts for muscular power and posture.
(2) The therapeutic exercise consisted of repetitive backward pulls on the patient's shoulders by the physical therapist. The physical therapist stood behind the patient and explained that they were allowed to take a step backward to avoid falling. The force of the pull was sufficient to displace the COG, at least to a degree requiring the patient to take a step backward. The instruction on how to land on the toes as a backward response was given orally before the pulls and numerous times during the therapeutic exercise.
Interventions/Control_2
<The control group>
The control group received the same intervention, but without the instructions.
The daily sessions lasted 40 min and consisted of 25 min of warm-up (1) followed by 15 min of therapeutic exercise (2). Weekends were excluded, so the therapeutic exercise was performed five times a week for 10 days in an ON medication stat.
(1) Warm-up included current physical therapy such as aerobic exercise, stretching, and high-amplitude movements, as well as active workouts for muscular power and posture.
(2) The therapeutic exercise consisted of repetitive backward pulls on the patient's shoulders by the physical therapist. The physical therapist stood behind the patient and explained that they were allowed to take a step backward to avoid falling. The force of the pull was sufficient to displace the COG, at least to a degree requiring the patient to take a step backward. In the control group, patients received the same therapeutic exercise program consisting of repetitive backward pulls on the shoulders, but they were not instructed how to land on their toes as a backward response.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Modified Hoehn and Yahr scale 2.5-4
(2) inpatient treatment
(3) ability to walk independently with or without a walking aid
Key exclusion criteria
(1) deep brain stimulation surgery
(2) dementia (Mini-Mental State Examination score of <24)
(3) uncontrolled chronic conditions that would interfere with the safety and conduct of the exercise
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Toshihide |
| Middle name | |
| Last name | Harada |
Organization
Prefectural University of Hiroshima
Division name
Graduate School of Comprehensive Scientific Research
Zip code
734-8558
Address
1-1-71, Ujina-higashi, Minami-ku, Hiroshima, Japan
TEL
+81-82-251-5178
hartoshi@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Taniuchi |
Organization
National Hospital Organization Hiroshima-Nishi Medical Center
Division name
Department of Rehabilitation
Zip code
739-0696
Address
4-1-1, Kuba, Otake, Hiroshima, Japan
TEL
+81-827-57-7151
Homepage URL
ehimeosaka@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Hiroshima-Nishi Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the National Hospital Organization Hiroshima-Nishi Medical Center's committee of ethics in research
Address
4-1-1, Kuba, Otake, Hiroshima, Japan
Tel
+81-827-57-7151
taniuchi.ryoma.da@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立病院機構広島西医療センター（広島県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
The improvement in the MDS-UPDRS part III scores was significantly greater for the INSTR group in the week-1 (P=0.033) and week-2 (P=0.004) assessments. However, provision of instructions to land on the toes as a backward response induced an improvement only in the scores related to the backward response, and no significant group differences were observed in the other outcomes.
Results date posted
| 2021 | Year | 08 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 11 | Day |
Last modified on
| 2022 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048762
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