Trial Outcomes & Findings for Effectiveness of Mirror Therapy in Stroke Patients With Unilateral Neglect - A Randomized Controlled Trial (NCT NCT01735877)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

48 participants

Primary outcome timeframe

Baseline, 1,3 and 6 months

Results posted on

2014-06-30

Participant Flow

Recruitment period: January 2011 to August 2013

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	27	21
Overall Study COMPLETED	26	21
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Mirror Therapy in Stroke Patients With Unilateral Neglect - A Randomized Controlled Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mirror Therapy n=27 Participants 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.	Control Group n=21 Participants 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.	Total n=48 Participants Total of all reporting groups
Age, Continuous	63.15 years STANDARD_DEVIATION 11.07 • n=5 Participants	64.29 years STANDARD_DEVIATION 12.02 • n=7 Participants	63.65 years STANDARD_DEVIATION 11.27 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment India	27 participants n=5 Participants	21 participants n=7 Participants	48 participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

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

Outcome measures

Outcome measures
Measure	Control Group n=20 Participants 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.	Mirror Therapy n=26 Participants 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.
Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months Baseline	18.20 units on a scale Interval 15.58 to 20.82	17.88 units on a scale Interval 15.91 to 19.85
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 5.60 • Interval 3.55 to 8.24	20.03 units on a scale 95% Confidence Interval 4.71 • Interval 17.98 to 22.09
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 • Interval 6.25 to 12.14	31.76 units on a scale 95% Confidence Interval 5.19 • Interval 29.18 to 34.35
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 • Interval 8.33 to 14.86	34.88 units on a scale 95% Confidence Interval 6.31 • Interval 32.02 to 37.74

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	Control Group n=20 Participants 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.	Mirror Therapy n=26 Participants 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.
Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months Baseline	0.45 cms Interval -4.87 to 5.77	2.28 cms Interval -2.14 to 6.7
Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months Baseline to 1 month	4.50 cms Interval 1.73 to 7.26	10.42 cms Interval 7.99 to 12.84
Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months Baseline to 3 month	9.55 cms Interval 5.1 to 13.99	18.26 cms Interval 14.37 to 22.16
Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months Baseline to 6 month	10.40 cms Interval 5.91 to 14.88	19.03 cms Interval 15.1 to 22.97

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	Control Group n=20 Participants 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.	Mirror Therapy n=26 Participants 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.
Change From Baseline in Picture Identification Task at 1,3, and 6 Months Baseline	4.20 pictures Interval 3.71 to 4.69	4.84 pictures Interval 4.64 to 5.04
Change From Baseline in Picture Identification Task at 1,3, and 6 Months Baseline to 1 month	1.2 pictures Interval 0.64 to 1.75	4.88 pictures Interval 4.38 to 5.37
Change From Baseline in Picture Identification Task at 1,3, and 6 Months Baseline to 3 month	1.75 pictures Interval 1.15 to 2.34	5.16 pictures Interval 4.62 to 5.69
Change From Baseline in Picture Identification Task at 1,3, and 6 Months Baseline to 6 month	1.95 pictures Interval 1.34 to 2.55	5.16 pictures Interval 4.62 to 5.69

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	Control Group n=21 Participants 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.	Mirror Therapy n=27 Participants 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.
Functional Independence Measure Dependent at Baseline	21 participants	27 participants
Functional Independence Measure Dependent at 1 month	20 participants	26 participants
Functional Independence Measure Dependent at 3 months	19 participants	18 participants
Functional Independence Measure Dependent at 6 months	19 participants	15 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Control Group n=21 Participants 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.	Mirror Therapy n=27 Participants 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.
Modified Rankin Scale (mRS) Poor outcome at Baseline	21 participants	27 participants
Modified Rankin Scale (mRS) Poor outcome at 1 month	20 participants	25 participants
Modified Rankin Scale (mRS) Poor outcome at 3 month	19 participants	16 participants
Modified Rankin Scale (mRS) Poor outcome at 6 month	19 participants	14 participants

Adverse Events

Mirror Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Jeyaraj D Pandian

Christian Medical College & Hospital

Phone: 09915784750

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place