SPIRIT 2013 checklist: Recommended items to address in a clinical trial protocol and related documents*.

SPIRIT 2013 checklist: Recommended items to address in a clinical trial protocol and related documents*.</p

Magnified prehensile activity by the non-paretic hand.

Magnified prehensile activity by the non-paretic hand.</p

Cone stacking task by the non-paretic upper limb.

BackgroundUnilateral spatial neglect (USN) is a commonly occurring neurocognitive disability after a stroke. The neglect may affect the motor recovery of the upper and lower limbs and functional performances. Mirror therapy, a simple and economical approach has the potential to reduce the USN and related impairments.AimThe primary objective of this study is to determine the effectiveness of task-based and magnified mirror therapy on the USN and on the motor recovery of the post-stroke subjects. The secondary objective is to investigate the effectiveness of the intervention on the function and disability of the subjects.MethodsIn this randomized controlled, assessor-blinded trial, 86 post-stroke subjects will be recruited from the neuro-rehabilitation laboratory of a rehabilitation institute, located in northern India. The participants,aged20 to 80 years, with 1 to 36 months of stroke onset, hemiparesis, and the USN, will be considered eligible for the study. In addition to the conventional rehabilitation, the experimental group(n = 43) will receive 40 sessions (8 weeks) of Task-based and MAGnified Mirror Therapy for Unilateral Spatial Neglect (T-MAGUSN). The control group (n = 43) will undergo a dose-matched conventional program only. The participants will be assessed at baseline, post-intervention and 4-week follow-up using primary (Line Bisection Test, Letter Cancellation Test, and Fugl-Myer Assessment) and secondary (Catherine Bergego Scale, Berg Balance Scale, Functional Ambulation Classification, Modified Rankin Scale) outcome measures.DiscussionThis proposed study will lead to the development of a novel rehabilitation protocol for the management of USN, aiming to enhance motor and functional recovery. The investigation will consider both the upper and lower limbs for the intervention, reducing the impact of cognitive disability in stroke.Trial registrationClinical Trial Registry of India (CTRI) as CTRI/2023/05/053184 (www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=74659).</div

The timeline for schedule of enrolment, intervention, and assessment as per SPIRIT guidelines.

t1 baseline assessment, t2 assessment after 8 weeks of intervention, t3 assessment after four-week follow-up (12 weeks after start of intervention). LCT = Letter Cancellation Task, LBT = Line Bisection Test, FMA = Fugl-Meyer assessment, CBS = Catherine Bergego Scale, BBS = Berg Balance Scale, FAC = Functional Ambulation Category, mRS = modified Rankin scale.</p

Rocker board activity by the non-paretic lower limb.

Rocker board activity by the non-paretic lower limb.</p

Flow of the study process.

BackgroundUnilateral spatial neglect (USN) is a commonly occurring neurocognitive disability after a stroke. The neglect may affect the motor recovery of the upper and lower limbs and functional performances. Mirror therapy, a simple and economical approach has the potential to reduce the USN and related impairments.AimThe primary objective of this study is to determine the effectiveness of task-based and magnified mirror therapy on the USN and on the motor recovery of the post-stroke subjects. The secondary objective is to investigate the effectiveness of the intervention on the function and disability of the subjects.MethodsIn this randomized controlled, assessor-blinded trial, 86 post-stroke subjects will be recruited from the neuro-rehabilitation laboratory of a rehabilitation institute, located in northern India. The participants,aged20 to 80 years, with 1 to 36 months of stroke onset, hemiparesis, and the USN, will be considered eligible for the study. In addition to the conventional rehabilitation, the experimental group(n = 43) will receive 40 sessions (8 weeks) of Task-based and MAGnified Mirror Therapy for Unilateral Spatial Neglect (T-MAGUSN). The control group (n = 43) will undergo a dose-matched conventional program only. The participants will be assessed at baseline, post-intervention and 4-week follow-up using primary (Line Bisection Test, Letter Cancellation Test, and Fugl-Myer Assessment) and secondary (Catherine Bergego Scale, Berg Balance Scale, Functional Ambulation Classification, Modified Rankin Scale) outcome measures.DiscussionThis proposed study will lead to the development of a novel rehabilitation protocol for the management of USN, aiming to enhance motor and functional recovery. The investigation will consider both the upper and lower limbs for the intervention, reducing the impact of cognitive disability in stroke.Trial registrationClinical Trial Registry of India (CTRI) as CTRI/2023/05/053184 (www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=74659).</div

S1 File -

BackgroundUnilateral spatial neglect (USN) is a commonly occurring neurocognitive disability after a stroke. The neglect may affect the motor recovery of the upper and lower limbs and functional performances. Mirror therapy, a simple and economical approach has the potential to reduce the USN and related impairments.AimThe primary objective of this study is to determine the effectiveness of task-based and magnified mirror therapy on the USN and on the motor recovery of the post-stroke subjects. The secondary objective is to investigate the effectiveness of the intervention on the function and disability of the subjects.MethodsIn this randomized controlled, assessor-blinded trial, 86 post-stroke subjects will be recruited from the neuro-rehabilitation laboratory of a rehabilitation institute, located in northern India. The participants,aged20 to 80 years, with 1 to 36 months of stroke onset, hemiparesis, and the USN, will be considered eligible for the study. In addition to the conventional rehabilitation, the experimental group(n = 43) will receive 40 sessions (8 weeks) of Task-based and MAGnified Mirror Therapy for Unilateral Spatial Neglect (T-MAGUSN). The control group (n = 43) will undergo a dose-matched conventional program only. The participants will be assessed at baseline, post-intervention and 4-week follow-up using primary (Line Bisection Test, Letter Cancellation Test, and Fugl-Myer Assessment) and secondary (Catherine Bergego Scale, Berg Balance Scale, Functional Ambulation Classification, Modified Rankin Scale) outcome measures.DiscussionThis proposed study will lead to the development of a novel rehabilitation protocol for the management of USN, aiming to enhance motor and functional recovery. The investigation will consider both the upper and lower limbs for the intervention, reducing the impact of cognitive disability in stroke.Trial registrationClinical Trial Registry of India (CTRI) as CTRI/2023/05/053184 (www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=74659).</div

The TIDieR (Template for Intervention Description and Replication) checklist*: Information to include when describing an intervention and the location of the information.

The TIDieR (Template for Intervention Description and Replication) checklist*: Information to include when describing an intervention and the location of the information.</p

Visual feedback of the paretic upper limb performance in the parasagittal plane.

Visual feedback of the paretic upper limb performance in the parasagittal plane.</p