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Task-oriented Training for Patients With Pusher Syndrome

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ClinicalTrials.gov Identifier: NCT05142670
Recruitment Status : Not yet recruiting
First Posted : December 2, 2021
Last Update Posted : December 2, 2021
Sponsor:
Information provided by (Responsible Party):
Qingping Tang, Hunan Provincial People's Hospital

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.


Condition or disease Intervention/treatment Phase
Pusher Syndrome Procedure: experimental group: task-oriented training individualized by the gravity perception Procedure: control group: visual feedback treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Task-oriented Training Varied by the Verticality Perception for Stroke Patients With Pusher Syndrome
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : January 1, 2026
Estimated Study Completion Date : January 1, 2026

Arm Intervention/treatment
Experimental: task-oriented training individualized by the gravity perception
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.
Procedure: experimental group: task-oriented training individualized by the gravity perception
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.

Active Comparator: visual feedback treatment
The training in the control group emphasizes the active use of visual feedback to facilitate reestablishing vertical position of the participants.
Procedure: control group: visual feedback treatment
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 Measures :
  1. Severity of pushing behavior [ Time Frame: 5 minutes ]
    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.

  2. Balance ability [ Time Frame: 5 minutes ]
    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.

  3. Motor ability [ Time Frame: 15 minutes ]
    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.

  4. MRI examinations [ Time Frame: 15 minutes ]
    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.

  5. Diffusion tensor imaging [ Time Frame: 15 minutes ]
    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.

  6. Postural vertical [ Time Frame: 5 minutes ]
    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.

  7. Visual vertical [ Time Frame: 5 minutes ]
    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.

  8. Haptic vertical [ Time Frame: 5 minutes ]
    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.



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Ages Eligible for Study:   40 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05142670


Contacts
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Contact: Qingping Tang +86-073185232387 tqingping1111@126.com
Contact: Xiaoye Wang, Study Chair

Locations
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China
Tang
Changsha, China, 410008
Sponsors and Collaborators
Hunan Provincial People's Hospital
Investigators
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Study Chair: Xiaoye Wang Brain Hospital of Hunan Province, Hunan University of Chinese Medicine
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Responsible Party: Qingping Tang, Director, Hunan Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT05142670    
Other Study ID Numbers: BHHP
First Posted: December 2, 2021    Key Record Dates
Last Update Posted: December 2, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qingping Tang, Hunan Provincial People's Hospital:
pusher syndrome
verticality perception
Task-oriented
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes