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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05985603
Other study ID # REC/01665 Bakhtawar Tariq
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date February 15, 2024

Study information

Verified date November 2023
Source Riphah International University
Contact Ayesha Bashir
Phone 03335256920
Email ayesha.bashir@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date February 15, 2024
Est. primary completion date January 30, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
CIMT Group
In this group of patients CIMT technique will be used for treatment
Mirror Therapy group
patient will perform movements in semi-reclined and sitting positions with the mirror placed between the two lower extremities.

Locations

Country Name City State
Pakistan Helping Hand Institute Of rehabilitation sciences Mansehra KPK

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (13)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 2,4,8 week
Primary 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 2,4,8 week
Primary 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. 2,4,8 week
Primary 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. 2,4,8 week
Primary 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. 2,4,8 week
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