Clinical trial NCT01735877: Effectiveness of Mirror Therapy in Stroke Patients With Unilateral Neglect - A Randomized Controlled Trial
Official title: Effectiveness of Mirror Therapy in Stroke Patients With Unilateral Neglect - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemispatial Neglect
Keywords: Hemispatial neglect, Stroke
Lead sponsor: Christian Medical College and Hospital, Ludhiana, India
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hemi spatial neglect, or the tendency to ignore stimuli originating in a portion of the environment contra lateral to a cerebral lesion, can be a major source of functional handicap after stroke. The currently available treatments for unilateral neglect are scanning training, visual cuing approaches, limb activation strategies, visual imagery, tactile stimulation, prisms and sustained attention training.Mirror therapy improves the hand function in sub-acute stroke.

Hypothesis: To evaluate the effectiveness of Mirror therapy in the management of stroke patients with unilateral neglect.

Detailed description: About 30 - 50% of stroke patients are left with considerable residual deficits. The post stroke disabilities are due to loss of locomotion and activities of daily living, cognition and communication skills.Hemispatial neglect has been reported in association with damage to several different cerebral structures in a large-scale distributed neurocognitive network.Mirror therapy improves the hand function in sub-acute stroke. It also helps in the recovery of neglect in stroke patients. But little consensus exists as to whether one treatment is more efficacious than others and many studies fail to document duration of treatment effects or generalization to daily activities. The aim of our study is to evaluate the effectiveness of limb activation with MT and limb activation strategy alone in the management of stroke patients with unilateral neglect and to make the patient functional in activities of daily living.

Eligibility criteria: Inclusion Criteria: 1.All stroke patients with parietal lobe and thalamic lesions 2. Stroke duration: within 48 hours 3. Patients willing to participate in the study 4. MRI/ CT scan showing parietal lobe and thalamic lesion 5. Patients with upper limb weakness

Exclusion Criteria:

1. Stroke duration more than 1 yr
2. Glasgow Coma Scale (GCS) of less than 7
3. Uncooperative patients

Primary outcomes:
measure: Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months
timeFrame: Baseline, 1,3 and 6 months
measure: Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months
timeFrame: Baseline, 1,3 and 6 months
measure: Change From Baseline in Picture Identification Task at 1,3, and 6 Months
timeFrame: Baseline, 1,3 and 6 months
Secondary outcomes:
measure: Functional Independence Measure
timeFrame: Baseline, 1, 3 and 6 months
measure: Modified Rankin Scale (mRS)
timeFrame: Baseline, 1,3 and 6 months
Other outcomes:
Locations:
city: Ludhiana
country: India
facility: Department of Neurology, CMC &H
state: Punjab
Study officials:
affiliation: BFUHS
name: Jeyaraj Pandian, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pandian JD, Arora R, Kaur P, Sharma D, Vishwambaran DK, Arima H. Mirror therapy in unilateral neglect after stroke (MUST trial): a randomized controlled trial. Neurology. 2014 Sep 9;83(11):1012-7. doi: 10.1212/WNL.0000000000000773. Epub 2014 Aug 8.