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Task-oriented Training for Patients With Pusher Syndrome

Primary Purpose

Pusher Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
experimental group: task-oriented training individualized by the gravity perception
control group: visual feedback treatment
Sponsored by
Hunan Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pusher Syndrome focused on measuring pusher syndrome, verticality perception, Task-oriented

Eligibility Criteria

40 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • (1) having the first cerebral ischemic stroke confirmed by magnetic resonance imaging; (2) presentation of hemiplegia; (3) onset of stroke within 1 month at the beginning of the physical therapy; (4) not receiving other physical therapy regimens aside from this intervention; (5) age 40 to 74 years old; (6) ability to execute simple verbal instructions; (7) not being delirious; (8) having stable vital signs and medical conditions.

Exclusion Criteria:

  • The exclusion criteria included diffuse brain damage, brain tumors, as well as other diseases such as acute subarachnoid hemorrhage, and/or severe cardiac and pulmonary disease, which were contraindicated in rehabilitation procedure.

Sites / Locations

  • Tang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

task-oriented training individualized by the gravity perception

visual feedback treatment

Arm Description

The training in the experimental group emphasizes the active use of intact or relatively preserved verticality perception to facilitate reestablishing vertical position of the participants. Additionally, a target such as an interesting person/object or an object with interesting music is used to direct the subject to accomplish a task in order to temporally desist from pathological pushing behavior.

The training in the control group emphasizes the active use of visual feedback to facilitate reestablishing vertical position of the participants.

Outcomes

Primary Outcome Measures

Severity of pushing behavior
Pushing behavior will be assessed using Burke Lateropulsion Scale, which is used to test postural responses to rolling, sitting, standing, transferring and walking with a total score ranging from 0 to 17. PS was identified in ischemic stroke patients with Burke Lateropulsion Scale scores equal or more than 2 during the initial assessment by the physical therapist. A higher score implies severe pusher behavior. The English and Chinese versions of the Burke Lateropulsion Scale have high validity and reliability.
Balance ability
The Berg Balance Scale will be used to assess balance and fall risk. This scale consists of 14 items with a total score ranging from 0 to 56. The Berg Balance Scale has a high validity and reliability in English and Chinese versions for evaluating balance ability in the stroke patients with a higher score indicating better performance.
Motor ability
Motor control ability will be assessed by Fugl-Meyer Assessment scale. This scale is scored by a three-point ordinal scale from 0 to 2, with maximum scores of 66 and 34 points for the upper and lower extremities, respectively. This scale has a high validity and reliability in English and Chinese versions with a higher score indicating better motor function.
MRI examinations
MRI examinations will be performed using a 32-channel head coil on a 3.0T MRI system (Philips, Ltd, Best, the Netherlands). MRI including T1- and T2-weighted fluid-attenuated inversion-recovery sequences, fat-suppressed images were acquired with 38 axial slices with an interslice gap of 3.3 mm.
Diffusion tensor imaging
Diffusion tensor images will be acquired using single-shot echoplanar imaging. Imaging parameters were as follows: acquisition matrix = 80 · 78, reconstructed to matrix = 128 · 128 matrix, field of view = 200 ·200 mm2, TR = 2214 milliseconds, TE = 82 milliseconds, parallel imaging reduction factor (SENSE factor) = 2, EPI factor = 39 and b = 800 s/mm2, NEX = 2, and a slice thickness of 3 mm without slice gap. The pathways including corticospinal tract, corticoreticular pathway, vestibular pathway to the parieto-insular vestibular cortex, the pathway to the medial lemniscus were tracked. The fraction anisotropy, mean diffusivity, axial diffusivity, radial diffusivity and tract volume of the selecting fibers were measured.
Postural vertical
The subject will be installed into a sitting position on a tilting device. The head was aligned with the trunk and lower limbs in in darkness. After the initial tilts ( -40 º and +40º) were set, the subject is gently and steadily tilted to the other side until the participant verbally indicated to have reached an upright position. Six repositioning trials will be conducted, three in each direction of movement. The initial position and performance feedback will be not given to the subjects in the procedure.
Visual vertical
The subject will be installed on a tilt bed which enabled testing in both supine, sitting or standing positions. The head will be aligned with the trunk in darkness. The visual vertical was measured using a luminous rod (25 cm long and 1.5 cm diameter) placed in front of subject at eye level. The luminous rod could be rotated within a range of ± 90º from the vertical level on a disk (25 cm in diameter). The orientation of the rod was measured by a digital inclinometer with an accuracy of 0.2º. After the initial tilts of the rod (0 º, -45 º and +45º) were set, the subject will be instructed to set the rod to earth vertical twice for each rod location in alternating sequence. Totally, six trials of rod rotation per body position were conducted.
Haptic vertical
The subject will be installed in a wheelchair on sitting positions with the head aligned with the trunk and lower limbs. Haptic vertical will be measured using a 40 cm long wooden rod presented in front of the subject at eye level. The subject will be instructed to place one hand above and one below the central of the rod. After the wooden rod will be offset by the therapist at 40° either to the right or left of true vertical during eye closure of the subject, the subject will be asked to set the rod to earth vertical with eyes closed. Totally, six trials of rod rotation per body position will be conducted. The orientation of the rod will be measured whit an angle ruler by two observers.

Secondary Outcome Measures

Full Information

First Posted
November 21, 2021
Last Updated
November 21, 2021
Sponsor
Hunan Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05142670
Brief Title
Task-oriented Training for Patients With Pusher Syndrome
Official Title
Task-oriented Training Varied by the Verticality Perception for Stroke Patients With Pusher Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunan Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Pusher syndrome (PS) has been considered to be one of the most intriguing affections that severely interferes with posture control and motor recovery of stroke patients during rehabilitation. However, there is no evidence that reported tailored treatments based on different types of the verticality perception for stroke patients with PS. The hypothesis of the study is that the task-oriented training varied by the verticality perception may increase the posture control and motor ability for pusher syndrome in stroke patients. Stroke participants with PS will be recruit and receive task-oriented training varied by the verticality perception. Severity of pushing behavior, balance ability, motor ability, verticality perception, and diffusion tensor imaging were evaluated.
Detailed Description
A randomized assigned, assessor-blinded trial will be execute in the experimental procedure. All participants will be divide into experimental group and control group. This study was approved by the Ethics Committee of Brain Hospital of Hunan Province, Hunan University of Chinese Medicine. An informed consent will be obtain from all participants. All stroke participants was diagnosed as Pusher syndrome (PS) with a score ≥2 in Burke Lateropulsion Scale. Clinical and demographic data, the Barthel Index and the Mini-Mental State Examination (MMSE) will be employed. The items of the sensory and visuospatial function in Stroke Impairments Assessment Set will be used. All participants in both groups received 50 minutes of physical therapy per session for 5 days per week for 8 weeks. Subjects in the experimental group underwent 20 minutes of task-oriented training individualized by the gravity perception following 30 minutes of regular physical therapy. Four therapists who had 2 or more years of physical therapy experience with stroke subjects provided the treatment. These therapists were equally assigned to the control group and to the experimental group. All outcome measurements were evaluated on the day before intervention (pretraining), 4 weeks and 8 weeks after training by the same physical therapist (who was blinded to the group of the subjects). Subjects in the control group underwent 20 minutes of visual feedback (VF) treatment. The regular physical therapy protocols for the control group were the same as those used for the experimental group. These regular protocols including preparatory techniques, mat activity, sitting, standing, and walking training have been previously reported. The training in the experimental group emphasizes the active use of intact or relatively preserved verticality perception (VP) to facilitate reestablishing vertical position of the participants. Additionally, a target such as an interesting person/object or an object with interesting music is used to direct the subject to accomplish a task in order to temporally desist from pathological pusher behavior. This training paradigm was composed of a series of steps. First, VP, pusher behavior, movement function and interesting focus were assessed. Second, relatively preserved VP and interesting focus, as well as problems of the VP, pusher behavior and movement were recorded. Third, realization of the disturbed perception of erect body position by the subjects was addressed. Because the subjects feel upright when their own body is actually tilted and vice versa. It is critically important that the subjects were aware of their disturbed VP in the recumbent, sitting, standing positions. To realize their disturbed VP, the subjects were instructed to actively explore the vertical structures as the reference objects by the relatively preserved VP. The vertical structures including door frame, windows, pillars, or bedrail et al. If the visual vertical of the subject was intact, the subject realized the vertical posture by visual perception through vertical structures and mirror. If the postural vertical of the subject was intact, the subject realized the vertical posture by postural perception with their eyes covered. If the haptic vertical of the subject was intact, the subject realized the vertical posture by place one hand above and one below the vertical structures with their eyes covered. Fourth, individualized treatment for the subject to reach the vertical posture were selected. This treatment would be mainly varied according to the relatively preserved VP and interesting focus of the subjects. If the visual vertical of the subject was intact, the subjects were instructed to visually align the vertical posture and to tilt to the nonparalyzed side by touching a target though referring to the vertical structures in front of the mirror. In this approach, therapists select family member or relations of the subjects, colorful and interesting objects or sound objects at the nonparetic side as the targets to direct the subjects to complete the vertical posture alignment. If the postural vertical of the subject was intact, the subjects were instructed to visualize the target, then to align the vertical posture and to tilt to the nonparalyzed side by touching the targets through the auditory instruction with their eyes covered. If the haptic vertical of the subject was intact, the subjects were also instructed to visualize the target, then to align the vertical posture and to tilt to the nonparalyzed side by touching the target through the trunk or both hands with their eyes covered. Fifth, repeated training was performed by using the relatively preserved VP until the subject regained midline. Then reaching the vertical body posture with the relatively preserved VP, the task, and vertical structure facilitating shifted to reaching the vertical body posture without the relatively preserved VP, the task, and the vertical structures facilitating. Sixth, the vertical body posture was maintained with and without the intact VP, the target, and vertical structure facilitating when the subject was actively and passively tilted to the paretic side. Seventh, the patients kept balance without any stimulators when the participants perform a variety of additional activities. Finally, reevaluation of the subjects and rearrangement of the treatment strategies was continued. The training in the control group received VF treatment program. Similarly, several steps were executed. First, the pusher behavior and movement function of the subject was evaluated, then the pusher behavior and movement problems were recorded. Second, realization of the disturbed VP was obtained by visual exploration of the whole body and vertical structures in front of the mirror. Third, the subjects were instructed to visually align the vertical posture and to tilt to the nonparalyzed side through referring to the vertical structures in front of the mirror. Fourth, repeated training was performed until the subject regained midline. Then reaching the vertical body posture visually in front of the mirror with the vertical structures facilitating shifted to reaching the vertical body posture without the visual vertical, mirror and vertical structures facilitating. Fifth, the vertical body posture was maintained with or without the visual vertical, mirror and vertical structures facilitating when the subject was actively and passively tilted to the paretic side. Sixth, the patients kept balance without any stimulators when the participants performed a variety of additional activities. Finally, reevaluation of the subjects and rearrangement of the treatment strategies was continued.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pusher Syndrome
Keywords
pusher syndrome, verticality perception, Task-oriented

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects in the experimental group underwent 20 minutes of task-oriented training individualized by the gravity perception following 30 minutes of regular physical therapy. The training in the control group received 20 minutes of visual feedback treatment program following 30 minutes of regular physical therapy.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
task-oriented training individualized by the gravity perception
Arm Type
Experimental
Arm Description
The training in the experimental group emphasizes the active use of intact or relatively preserved verticality perception to facilitate reestablishing vertical position of the participants. Additionally, a target such as an interesting person/object or an object with interesting music is used to direct the subject to accomplish a task in order to temporally desist from pathological pushing behavior.
Arm Title
visual feedback treatment
Arm Type
Active Comparator
Arm Description
The training in the control group emphasizes the active use of visual feedback to facilitate reestablishing vertical position of the participants.
Intervention Type
Procedure
Intervention Name(s)
experimental group: task-oriented training individualized by the gravity perception
Intervention Description
All participants received 50 minutes of physical therapy per session for 5 days per week for 8 weeks. Subjects in the experimental group underwent 20 minutes of task-oriented training individualized by the gravity perception following 30 minutes of regular physical therapy. All outcome measurements were evaluated on the day before intervention (pretraining), 4 weeks and 8 weeks after training by the same physical therapist (who was blinded to the group of the subjects). These regular protocols including preparatory techniques, mat activity, sitting, standing, and walking training.
Intervention Type
Procedure
Intervention Name(s)
control group: visual feedback treatment
Intervention Description
Subjects in the control group underwent 20 minutes of visual feedback (VF) treatment. The regular physical therapy protocols for the control group were the same as those used for the experimental group. These regular protocols including preparatory techniques, mat activity, sitting, standing, and walking training.
Primary Outcome Measure Information:
Title
Severity of pushing behavior
Description
Pushing behavior will be assessed using Burke Lateropulsion Scale, which is used to test postural responses to rolling, sitting, standing, transferring and walking with a total score ranging from 0 to 17. PS was identified in ischemic stroke patients with Burke Lateropulsion Scale scores equal or more than 2 during the initial assessment by the physical therapist. A higher score implies severe pusher behavior. The English and Chinese versions of the Burke Lateropulsion Scale have high validity and reliability.
Time Frame
5 minutes
Title
Balance ability
Description
The Berg Balance Scale will be used to assess balance and fall risk. This scale consists of 14 items with a total score ranging from 0 to 56. The Berg Balance Scale has a high validity and reliability in English and Chinese versions for evaluating balance ability in the stroke patients with a higher score indicating better performance.
Time Frame
5 minutes
Title
Motor ability
Description
Motor control ability will be assessed by Fugl-Meyer Assessment scale. This scale is scored by a three-point ordinal scale from 0 to 2, with maximum scores of 66 and 34 points for the upper and lower extremities, respectively. This scale has a high validity and reliability in English and Chinese versions with a higher score indicating better motor function.
Time Frame
15 minutes
Title
MRI examinations
Description
MRI examinations will be performed using a 32-channel head coil on a 3.0T MRI system (Philips, Ltd, Best, the Netherlands). MRI including T1- and T2-weighted fluid-attenuated inversion-recovery sequences, fat-suppressed images were acquired with 38 axial slices with an interslice gap of 3.3 mm.
Time Frame
15 minutes
Title
Diffusion tensor imaging
Description
Diffusion tensor images will be acquired using single-shot echoplanar imaging. Imaging parameters were as follows: acquisition matrix = 80 · 78, reconstructed to matrix = 128 · 128 matrix, field of view = 200 ·200 mm2, TR = 2214 milliseconds, TE = 82 milliseconds, parallel imaging reduction factor (SENSE factor) = 2, EPI factor = 39 and b = 800 s/mm2, NEX = 2, and a slice thickness of 3 mm without slice gap. The pathways including corticospinal tract, corticoreticular pathway, vestibular pathway to the parieto-insular vestibular cortex, the pathway to the medial lemniscus were tracked. The fraction anisotropy, mean diffusivity, axial diffusivity, radial diffusivity and tract volume of the selecting fibers were measured.
Time Frame
15 minutes
Title
Postural vertical
Description
The subject will be installed into a sitting position on a tilting device. The head was aligned with the trunk and lower limbs in in darkness. After the initial tilts ( -40 º and +40º) were set, the subject is gently and steadily tilted to the other side until the participant verbally indicated to have reached an upright position. Six repositioning trials will be conducted, three in each direction of movement. The initial position and performance feedback will be not given to the subjects in the procedure.
Time Frame
5 minutes
Title
Visual vertical
Description
The subject will be installed on a tilt bed which enabled testing in both supine, sitting or standing positions. The head will be aligned with the trunk in darkness. The visual vertical was measured using a luminous rod (25 cm long and 1.5 cm diameter) placed in front of subject at eye level. The luminous rod could be rotated within a range of ± 90º from the vertical level on a disk (25 cm in diameter). The orientation of the rod was measured by a digital inclinometer with an accuracy of 0.2º. After the initial tilts of the rod (0 º, -45 º and +45º) were set, the subject will be instructed to set the rod to earth vertical twice for each rod location in alternating sequence. Totally, six trials of rod rotation per body position were conducted.
Time Frame
5 minutes
Title
Haptic vertical
Description
The subject will be installed in a wheelchair on sitting positions with the head aligned with the trunk and lower limbs. Haptic vertical will be measured using a 40 cm long wooden rod presented in front of the subject at eye level. The subject will be instructed to place one hand above and one below the central of the rod. After the wooden rod will be offset by the therapist at 40° either to the right or left of true vertical during eye closure of the subject, the subject will be asked to set the rod to earth vertical with eyes closed. Totally, six trials of rod rotation per body position will be conducted. The orientation of the rod will be measured whit an angle ruler by two observers.
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (1) having the first cerebral ischemic stroke confirmed by magnetic resonance imaging; (2) presentation of hemiplegia; (3) onset of stroke within 1 month at the beginning of the physical therapy; (4) not receiving other physical therapy regimens aside from this intervention; (5) age 40 to 74 years old; (6) ability to execute simple verbal instructions; (7) not being delirious; (8) having stable vital signs and medical conditions. Exclusion Criteria: The exclusion criteria included diffuse brain damage, brain tumors, as well as other diseases such as acute subarachnoid hemorrhage, and/or severe cardiac and pulmonary disease, which were contraindicated in rehabilitation procedure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingping Tang
Phone
+86-073185232387
Email
tqingping1111@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoye Wang, Study Chair
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoye Wang
Organizational Affiliation
Brain Hospital of Hunan Province, Hunan University of Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Tang
City
Changsha
ZIP/Postal Code
410008
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Task-oriented Training for Patients With Pusher Syndrome

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