Back to resultsComparison of Mirror Therapy and Modified Constrain Induced Movement Therapy on Risk of Fall, Balance and Gait in Stroke
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
CIMT Group
Mirror Therapy group
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring CIMT, Mirror Therapy
Eligibility Criteria
Inclusion Criteria: A Hemiplegia due to unilateral stroke Sub-acute and chronic stroke Stroke survivors between 21 and 70 years old will be recruited Both genders NIH Stroke scale below 20 Mini-Mental State Examination above 24 Function in Sitting Test (FIST) above 42/56 Exclusion Criteria: Patients with depression who will be unable to cooperate during treatment Patients who cannot perform the active movement of limb due to prestroke muscoskeletal problems Cardiopulmonary diseases which could hinder their ability to participate in rehabilitation Spasticity of Modified Ashworth Scale (MAS) II or higher Patients with Any neuron disease and Patients with lower-limb impairment caused by other neurological diseases or inability to comply with study protocol will be excluded. Visual and auditory abnormalities
Sites / Locations
- Helping Hand Institute Of rehabilitation sciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CIMT Group
Mirror Therapy Group
Arm Description
In this group of patients CIMT technique will be used for treatment
patient will perform movements in semi-reclined and sitting positions with the mirror placed between the two lower extremities.
Outcomes
Primary Outcome Measures
NIH Stroke Scale - NIHSS
It comprises of 15 items with each having responses scored on a 0-4 points scale. The overall score ranges from 0-42 points with higher scores specifying pronounced neurological deficits
Mini-mental state examination
Cognitive status by the mini-mental state examination (mmse)Mini-Mental State Examination (MMSE) is a tool that can quickly diagnose if a person suffers from mild cognitive impairment (MCI) through answering questions in different cognitive domains. The MMSE demonstrates moderately high levels of reliability. It has been reported to be internally consistent
POMA
After interventions POMA for assessing risk of fall will be used. The POMA is used to examine balance and mobility in the elderly (Tinetti 1986). This examination tool consists of the balance subscale (9 items, 16 points) and gait subscale (8 items, 12 points), totaling 28 points.
Berg balance scale
A five-point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 0-56. Score of 41-56 = low fall risk, 21-40 = medium fall risk, 0-20 = high fall risk.
10 Meter walk test / 10mwt
Calculating Gait Speed - total distance/time. For example: if you did a 10-meter gait speed test and it took you 7 seconds, the equation would like: 10 meters / 7 seconds = 1.4 meters per second. The 10MWT intra-rater and inter-rater reliability were good (ICC between 0.76 until 0.9) and excellent (ICC > 0.9), respectively. The minimal detectable change for intra-rater reliability was 0.188 m/s.
Secondary Outcome Measures
Full Information
NCT ID
NCT05985603
First Posted
August 3, 2023
Last Updated
August 3, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05985603
Brief Title
Comparison of Mirror Therapy and Modified Constrain Induced Movement Therapy on Risk of Fall, Balance and Gait in Stroke
Official Title
Comparison of Mirror Therapy and Modified Constrain Induced Movement Therapy on Risk of Fall, Balance and Gait in Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
There will be a difference between modified constraint induced movement therapy and Mirror Therapy on lower limb for risk of fall, balance and gait in stroke patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
CIMT, Mirror Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CIMT Group
Arm Type
Experimental
Arm Description
In this group of patients CIMT technique will be used for treatment
Arm Title
Mirror Therapy Group
Arm Type
Experimental
Arm Description
patient will perform movements in semi-reclined and sitting positions with the mirror placed between the two lower extremities.
Intervention Type
Other
Intervention Name(s)
CIMT Group
Intervention Description
In this group of patients CIMT technique will be used for treatment
Intervention Type
Other
Intervention Name(s)
Mirror Therapy group
Intervention Description
patient will perform movements in semi-reclined and sitting positions with the mirror placed between the two lower extremities.
Primary Outcome Measure Information:
Title
NIH Stroke Scale - NIHSS
Description
It comprises of 15 items with each having responses scored on a 0-4 points scale. The overall score ranges from 0-42 points with higher scores specifying pronounced neurological deficits
Time Frame
2,4,8 week
Title
Mini-mental state examination
Description
Cognitive status by the mini-mental state examination (mmse)Mini-Mental State Examination (MMSE) is a tool that can quickly diagnose if a person suffers from mild cognitive impairment (MCI) through answering questions in different cognitive domains. The MMSE demonstrates moderately high levels of reliability. It has been reported to be internally consistent
Time Frame
2,4,8 week
Title
POMA
Description
After interventions POMA for assessing risk of fall will be used. The POMA is used to examine balance and mobility in the elderly (Tinetti 1986). This examination tool consists of the balance subscale (9 items, 16 points) and gait subscale (8 items, 12 points), totaling 28 points.
Time Frame
2,4,8 week
Title
Berg balance scale
Description
A five-point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 0-56. Score of 41-56 = low fall risk, 21-40 = medium fall risk, 0-20 = high fall risk.
Time Frame
2,4,8 week
Title
10 Meter walk test / 10mwt
Description
Calculating Gait Speed - total distance/time. For example: if you did a 10-meter gait speed test and it took you 7 seconds, the equation would like: 10 meters / 7 seconds = 1.4 meters per second. The 10MWT intra-rater and inter-rater reliability were good (ICC between 0.76 until 0.9) and excellent (ICC > 0.9), respectively. The minimal detectable change for intra-rater reliability was 0.188 m/s.
Time Frame
2,4,8 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A Hemiplegia due to unilateral stroke
Sub-acute and chronic stroke
Stroke survivors between 21 and 70 years old will be recruited
Both genders
NIH Stroke scale below 20
Mini-Mental State Examination above 24
Function in Sitting Test (FIST) above 42/56
Exclusion Criteria:
Patients with depression who will be unable to cooperate during treatment
Patients who cannot perform the active movement of limb due to prestroke muscoskeletal problems
Cardiopulmonary diseases which could hinder their ability to participate in rehabilitation
Spasticity of Modified Ashworth Scale (MAS) II or higher
Patients with Any neuron disease and Patients with lower-limb impairment caused by other neurological diseases or inability to comply with study protocol will be excluded.
Visual and auditory abnormalities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayesha Bashir
Phone
03335256920
Email
ayesha.bashir@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayesha Bashir, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helping Hand Institute Of rehabilitation sciences
City
Mansehra
State/Province
KPK
ZIP/Postal Code
21300
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayesha Basheer, MSNMPT
Phone
+92 333 5256920
Email
ayesha.bashir@riphah.edu.pk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35793900
Citation
Oh K, Im N, Lee Y, Lim N, Cho T, Ryu S, Yoon S. Effect of Antigravity Treadmill Gait Training on Gait Function and Fall Risk in Stroke Patients. Ann Rehabil Med. 2022 Jun;46(3):114-121. doi: 10.5535/arm.22034. Epub 2022 Jun 30.
Results Reference
background
PubMed Identifier
36189374
Citation
Okonkwo UP, Agbo CF, Ibeneme SC, Igwe ES, Akosile CO, Onwuakagba IU, Emmanuel OC, Maduagwu SM, Ezenwankwo EF, Ekechukwu EN. The Burden and Quality of life of Caregivers of Stroke Survivors with Cognitive Impairment in Selected Healthcare Facilities in Anambra State, Nigeria. Gerontol Geriatr Med. 2022 Sep 27;8:23337214221126329. doi: 10.1177/23337214221126329. eCollection 2022 Jan-Dec.
Results Reference
background
PubMed Identifier
30741610
Citation
Wagatsuma M, Kim T, Sitagata P, Lee E, Vrongistinos K, Jung T. The biomechanical investigation of the relationship between balance and muscular strength in people with chronic stroke: a pilot cross-sectional study. Top Stroke Rehabil. 2019 Apr;26(3):173-179. doi: 10.1080/10749357.2019.1574417. Epub 2019 Feb 11.
Results Reference
background
PubMed Identifier
36554493
Citation
Khan F, Abusharha S, Alfuraidy A, Nimatallah K, Almalki R, Basaffar R, Mirdad M, Chevidikunnan MF, Basuodan R. Prediction of Factors Affecting Mobility in Patients with Stroke and Finding the Mediation Effect of Balance on Mobility: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Dec 10;19(24):16612. doi: 10.3390/ijerph192416612.
Results Reference
background
PubMed Identifier
31326927
Citation
Li J, Zhong D, Ye J, He M, Liu X, Zheng H, Jin R, Zhang SL. Rehabilitation for balance impairment in patients after stroke: a protocol of a systematic review and network meta-analysis. BMJ Open. 2019 Jul 19;9(7):e026844. doi: 10.1136/bmjopen-2018-026844.
Results Reference
background
PubMed Identifier
31323068
Citation
Arienti C, Lazzarini SG, Pollock A, Negrini S. Rehabilitation interventions for improving balance following stroke: An overview of systematic reviews. PLoS One. 2019 Jul 19;14(7):e0219781. doi: 10.1371/journal.pone.0219781. eCollection 2019.
Results Reference
background
PubMed Identifier
29153043
Citation
Herrador Colmenero L, Perez Marmol JM, Marti-Garcia C, Querol Zaldivar MLA, Tapia Haro RM, Castro Sanchez AM, Aguilar-Ferrandiz ME. Effectiveness of mirror therapy, motor imagery, and virtual feedback on phantom limb pain following amputation: A systematic review. Prosthet Orthot Int. 2018 Jun;42(3):288-298. doi: 10.1177/0309364617740230. Epub 2017 Nov 20.
Results Reference
background
PubMed Identifier
29410571
Citation
Ju Y, Yoon IJ. The effects of modified constraint-induced movement therapy and mirror therapy on upper extremity function and its influence on activities of daily living. J Phys Ther Sci. 2018 Jan;30(1):77-81. doi: 10.1589/jpts.30.77. Epub 2018 Jan 27.
Results Reference
background
PubMed Identifier
36584748
Citation
Garrido M M, Alvarez E E, Acevedo P F, Moyano V A, Castillo N N, Cavada Ch G. Early transcranial direct current stimulation with modified constraint-induced movement therapy for motor and functional upper limb recovery in hospitalized patients with stroke: A randomized, multicentre, double-blind, clinical trial. Brain Stimul. 2023 Jan-Feb;16(1):40-47. doi: 10.1016/j.brs.2022.12.008. Epub 2022 Dec 28.
Results Reference
background
PubMed Identifier
28859603
Citation
E Silva EMGS, Ribeiro TS, da Silva TCC, Costa MFP, Cavalcanti FADC, Lindquist ARR. Effects of constraint-induced movement therapy for lower limbs on measurements of functional mobility and postural balance in subjects with stroke: a randomized controlled trial. Top Stroke Rehabil. 2017 Dec;24(8):555-561. doi: 10.1080/10749357.2017.1366011. Epub 2017 Aug 31.
Results Reference
background
PubMed Identifier
35801093
Citation
Wang D, Xiang J, He Y, Yuan M, Dong L, Ye Z, Mao W. The Mechanism and Clinical Application of Constraint-Induced Movement Therapy in Stroke Rehabilitation. Front Behav Neurosci. 2022 Jun 21;16:828599. doi: 10.3389/fnbeh.2022.828599. eCollection 2022.
Results Reference
background
PubMed Identifier
25229024
Citation
Yoon JA, Koo BI, Shin MJ, Shin YB, Ko HY, Shin YI. Effect of constraint-induced movement therapy and mirror therapy for patients with subacute stroke. Ann Rehabil Med. 2014 Aug;38(4):458-66. doi: 10.5535/arm.2014.38.4.458. Epub 2014 Aug 28.
Results Reference
background
PubMed Identifier
27065534
Citation
Kim K, Lee S, Kim D, Lee K, Kim Y. Effects of mirror therapy combined with motor tasks on upper extremity function and activities daily living of stroke patients. J Phys Ther Sci. 2016 Jan;28(2):483-7. doi: 10.1589/jpts.28.483. Epub 2016 Feb 29.
Results Reference
background
Learn more about this trial
Comparison of Mirror Therapy and Modified Constrain Induced Movement Therapy on Risk of Fall, Balance and Gait in Stroke
We'll reach out to this number within 24 hrs