Task-oriented Training for Patients With Pusher Syndrome

NCT ID: NCT05142670

Last Updated: 2021-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2026-01-01

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.

Conditions

Pusher Syndrome

Keywords

pusher syndrome; verticality perception; Task-oriented

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

experimental group: task-oriented training individualized by the gravity perception

Intervention Type: PROCEDURE

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.

visual feedback treatment

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

Group Type: ACTIVE_COMPARATOR

control group: visual feedback treatment

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Qingping Tang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoye Wang

Role: STUDY_CHAIR

Brain Hospital of Hunan Province, Hunan University of Chinese Medicine

Locations

Tang

Changsha, , China

Countries

China

Central Contacts

Qingping Tang

Role: CONTACT

Phone: +86-073185232387

Email: tqingping1111@126.com

Xiaoye Wang, Study Chair

Role: CONTACT

Other Identifiers

BHHP

Identifier Type: -

Identifier Source: org_study_id