Hemispatial Neglect
Conditions
Keywords
Hemispatial neglect, Stroke
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.
Interventions
OTHERMirror therapy
During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
OTHERControl group
The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation.
Sponsors
Christian Medical College and Hospital, Ludhiana, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months | Baseline, 1,3 and 6 months | The SCT consisted of a page containing 52 large stars, 10 short words and 13 letters, randomly positioned, with 56 small stars interspersed. Subjects were instructed to cross out (with a black pen) all the small stars across the page. The tester demonstrated by crossing out the two central stars. The cut off score to establish presence of unilateral visual neglect were: 51 or fewer stars cancelled for SCT. Minimum score: 0 Maximum score: 54 Higher scores: better outcome |
| Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months | Baseline, 1,3 and 6 months | The Line Bisection Test (LBT) consisted of three horizontal black lines, 20 cm long, one to the right, one central and one to the left side of a sheet of white paper (21cms X 30 cms). The patients were asked to find and mark the centre of each line in turn. Errors away from true midline were measured, with leftward errors being given a negative sign, rightward errors a positive sign. We took an absolute value for the change in error. The values for baseline to 1 month were calculated by subtracting baseline values from 1 month values. Then, the mean change was calculated for baseline to 1 month. Similar method was followed for the calculation of mean change in baseline to 3 months and 6 months. The patients responses were similar for the three lines that they marked hence we took the first line for the interpretation. None of the patients had extreme errors like missed marking at 3 and 6 months. |
| Change From Baseline in Picture Identification Task at 1,3, and 6 Months | Baseline, 1,3 and 6 months | PIT consisted of 10 pictures on A4 size paper and patients were asked to identify pictures. More the number of pictures identified, lesser was the neglect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Independence Measure | Baseline, 1, 3 and 6 months | The FIM consists of 13 motor and 5 social-cognitive items, assessing self-care, sphincter management, transfer, locomotion, communication, social interaction and cognition.14 It uses a 7-level scale anchored by extreme rating of total dependence as 1 and complete independence as 7; the intermediate levels are: 6 modified independence, 5 supervision or set-up, 4 minimal contact assistance, 3 moderate assistance and 2 maximal assistance. For the purpose of analysis we divided FIM into two categories ≤5 dependent, ≥6 independent. |
| Modified Rankin Scale (mRS) | Baseline, 1,3 and 6 months | 0 - No symptoms at all / 1 - No significant disability despite symptoms / 2 - Slight disability / 3 -Moderate disability, but able to walk without assistance / 4 - Moderate disability and unable to walk without assistance / 5 - Severe disability / 6 - death 0-2: Good outcome 3-6: Poor outcome |
Countries
India
Participant flow
Recruitment details
Recruitment period: January 2011 to August 2013
Participants by arm
| Arm | Count |
|---|---|
| Mirror Therapy Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand. | 27 |
| Control Group Group 2 will be given sham mirror therapy
Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation. | 21 |
| Total | 48 |
Baseline characteristics
| Characteristic | Mirror Therapy | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 63.15 years STANDARD_DEVIATION 11.07 | 64.29 years STANDARD_DEVIATION 12.02 | 63.65 years STANDARD_DEVIATION 11.27 |
| Region of Enrollment India | 27 participants | 21 participants | 48 participants |
| Sex: Female, Male Female | 13 Participants | 7 Participants | 20 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 21 |
| serious Total, serious adverse events | 0 / 27 | 0 / 21 |
Outcome results
Primary
Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months
The Line Bisection Test (LBT) consisted of three horizontal black lines, 20 cm long, one to the right, one central and one to the left side of a sheet of white paper (21cms X 30 cms). The patients were asked to find and mark the centre of each line in turn. Errors away from true midline were measured, with leftward errors being given a negative sign, rightward errors a positive sign. We took an absolute value for the change in error. The values for baseline to 1 month were calculated by subtracting baseline values from 1 month values. Then, the mean change was calculated for baseline to 1 month. Similar method was followed for the calculation of mean change in baseline to 3 months and 6 months. The patients responses were similar for the three lines that they marked hence we took the first line for the interpretation. None of the patients had extreme errors like missed marking at 3 and 6 months.
Time frame: Baseline, 1,3 and 6 months
Population: The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mirror Therapy | Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months | Baseline | 2.28 cms |
| Mirror Therapy | Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months | Baseline to 1 month | 10.42 cms |
| Mirror Therapy | Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months | Baseline to 3 month | 18.26 cms |
| Mirror Therapy | Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months | Baseline to 6 month | 19.03 cms |
| Control Group | Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months | Baseline to 6 month | 10.40 cms |
| Control Group | Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months | Baseline | 0.45 cms |
| Control Group | Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months | Baseline to 3 month | 9.55 cms |
| Control Group | Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months | Baseline to 1 month | 4.50 cms |
Comparison: At Baselinep-value: 0.64t-test, 2 sided
Comparison: Mean change from baseline to 1 monthp-value: 0.00295% CI: [2.24, 9.6]ANCOVA
Comparison: Mean change from baseline to 3 monthp-value: 0.00595% CI: [2.8, 14.63]ANCOVA
Comparison: Mean change from baseline to 6 monthp-value: 0.00695% CI: [2.67, 14.6]ANCOVA
Primary
Change From Baseline in Picture Identification Task at 1,3, and 6 Months
PIT consisted of 10 pictures on A4 size paper and patients were asked to identify pictures. More the number of pictures identified, lesser was the neglect.
Time frame: Baseline, 1,3 and 6 months
Population: The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mirror Therapy | Change From Baseline in Picture Identification Task at 1,3, and 6 Months | Baseline | 4.84 pictures |
| Mirror Therapy | Change From Baseline in Picture Identification Task at 1,3, and 6 Months | Baseline to 1 month | 4.88 pictures |
| Mirror Therapy | Change From Baseline in Picture Identification Task at 1,3, and 6 Months | Baseline to 3 month | 5.16 pictures |
| Mirror Therapy | Change From Baseline in Picture Identification Task at 1,3, and 6 Months | Baseline to 6 month | 5.16 pictures |
| Control Group | Change From Baseline in Picture Identification Task at 1,3, and 6 Months | Baseline to 6 month | 1.95 pictures |
| Control Group | Change From Baseline in Picture Identification Task at 1,3, and 6 Months | Baseline | 4.20 pictures |
| Control Group | Change From Baseline in Picture Identification Task at 1,3, and 6 Months | Baseline to 3 month | 1.75 pictures |
| Control Group | Change From Baseline in Picture Identification Task at 1,3, and 6 Months | Baseline to 1 month | 1.2 pictures |
Comparison: Baselinep-value: 0.99t-test, 2 sided
Comparison: Mean change from baseline to 1 monthp-value: <0.000195% CI: [2.93, 4.42]ANCOVA
Comparison: Mean change from baseline to 3 monthp-value: <0.000195% CI: [2.61, 4.21]ANCOVA
Comparison: Mean change from baseline to 6 monthp-value: <0.000195% CI: [2.4, 4.02]ANCOVA
Primary
Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months
The SCT consisted of a page containing 52 large stars, 10 short words and 13 letters, randomly positioned, with 56 small stars interspersed. Subjects were instructed to cross out (with a black pen) all the small stars across the page. The tester demonstrated by crossing out the two central stars. The cut off score to establish presence of unilateral visual neglect were: 51 or fewer stars cancelled for SCT. Minimum score: 0 Maximum score: 54 Higher scores: better outcome
Time frame: Baseline, 1,3 and 6 months
Population: The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirror Therapy | Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months | Baseline | 17.88 units on a scale | — |
| Mirror Therapy | Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months | Baseline to 1 month | 20.03 units on a scale | 95% Confidence Interval 4.71 |
| Mirror Therapy | Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months | Baseline to 3 month | 31.76 units on a scale | 95% Confidence Interval 5.19 |
| Mirror Therapy | Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months | Baseline to 6 month | 34.88 units on a scale | 95% Confidence Interval 6.31 |
| Control Group | Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months | Baseline to 6 month | 11.60 units on a scale | 95% Confidence Interval 6.01 |
| Control Group | Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months | Baseline | 18.20 units on a scale | — |
| Control Group | Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months | Baseline to 3 month | 9.2 units on a scale | 95% Confidence Interval 3.44 |
| Control Group | Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months | Baseline to 1 month | 5.90 units on a scale | 95% Confidence Interval 5.6 |
Comparison: At Baselinep-value: 0.77t-test, 2 sided
Comparison: Mean Change from baseline to 1 monthp-value: <0.000195% CI: [11.02, 17.25]ANCOVA
Comparison: Baseline to 3 monthp-value: <0.000195% CI: [18.65, 26.48]ANCOVA
Comparison: Baseline to 6 monthp-value: <0.000195% CI: [18.94, 27.62]ANCOVA
Secondary
Functional Independence Measure
The FIM consists of 13 motor and 5 social-cognitive items, assessing self-care, sphincter management, transfer, locomotion, communication, social interaction and cognition.14 It uses a 7-level scale anchored by extreme rating of total dependence as 1 and complete independence as 7; the intermediate levels are: 6 modified independence, 5 supervision or set-up, 4 minimal contact assistance, 3 moderate assistance and 2 maximal assistance. For the purpose of analysis we divided FIM into two categories ≤5 dependent, ≥6 independent.
Time frame: Baseline, 1, 3 and 6 months
Population: The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirror Therapy | Functional Independence Measure | Dependent at Baseline | 27 participants |
| Mirror Therapy | Functional Independence Measure | Dependent at 1 month | 26 participants |
| Mirror Therapy | Functional Independence Measure | Dependent at 6 months | 15 participants |
| Mirror Therapy | Functional Independence Measure | Dependent at 3 months | 18 participants |
| Control Group | Functional Independence Measure | Dependent at 6 months | 19 participants |
| Control Group | Functional Independence Measure | Dependent at Baseline | 21 participants |
| Control Group | Functional Independence Measure | Dependent at 1 month | 20 participants |
| Control Group | Functional Independence Measure | Dependent at 3 months | 19 participants |
Comparison: At Baselinep-value: 0.99Chi-squared
Comparison: At 1 monthp-value: 0.99Chi-squared
Comparison: At 3 monthsp-value: 0.03Chi-squared
Comparison: At 6 monthsp-value: 0.004Chi-squared
Secondary
Modified Rankin Scale (mRS)
0 - No symptoms at all / 1 - No significant disability despite symptoms / 2 - Slight disability / 3 -Moderate disability, but able to walk without assistance / 4 - Moderate disability and unable to walk without assistance / 5 - Severe disability / 6 - death 0-2: Good outcome 3-6: Poor outcome
Time frame: Baseline, 1,3 and 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirror Therapy | Modified Rankin Scale (mRS) | Poor outcome at Baseline | 27 participants |
| Mirror Therapy | Modified Rankin Scale (mRS) | Poor outcome at 1 month | 25 participants |
| Mirror Therapy | Modified Rankin Scale (mRS) | Poor outcome at 3 month | 16 participants |
| Mirror Therapy | Modified Rankin Scale (mRS) | Poor outcome at 6 month | 14 participants |
| Control Group | Modified Rankin Scale (mRS) | Poor outcome at 6 month | 19 participants |
| Control Group | Modified Rankin Scale (mRS) | Poor outcome at Baseline | 21 participants |
| Control Group | Modified Rankin Scale (mRS) | Poor outcome at 3 month | 19 participants |
| Control Group | Modified Rankin Scale (mRS) | Poor outcome at 1 month | 20 participants |
Comparison: At Baselinep-value: 0.99Chi-squared
Comparison: At month 1p-value: 0.99Chi-squared
Comparison: At month 3p-value: 0.04Chi-squared
Comparison: At month 6p-value: 0.01Chi-squared