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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05931172
Other study ID # REC/LHR/23/0224 nadia
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 25, 2023
Est. completion date October 30, 2023

Study information

Verified date July 2023
Source Riphah International University
Contact Imran Amjad
Phone 03324390125
Email mran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare the effect of dual tasking and proprioceptive neuromuscular facilitation on balance, cognition and motor function in chronic stroke patients. It will be randomized clinical trial.


Description:

Stroke is the major cause of disability and mortality worldwide. A stroke is defined as an abrupt neurological outburst caused by impaired perfusion through the blood vessels to the brain. Every year the number of patients affected by stroke is rising thereby putting extra pressure on socioeconomic conditions in developing countries. Major complications of stroke include hemiplegia leading to upper limb dysfunction along with gait abnormalities. This study will be conducted to determine the effects of proprioceptive neuromuscular facilitation exercises versus dual-task training on balance, cognition, and motor function in chronic stroke patients. The randomized clinical trial will be conducted, participants will be selected through Non-probability convenience sampling technique and then randomly allocated into two treatment groups.


Recruitment information / eligibility

Status Recruiting
Enrollment 32
Est. completion date October 30, 2023
Est. primary completion date October 18, 2023
Accepts healthy volunteers No
Gender All
Age group 50 Years to 70 Years
Eligibility Inclusion Criteria: item - Both male and female - Age 50-70 years. - Person should be able to walk 10meter distance with or without assistance. - Patient should be Cognitively able to perform required task. - Chronic Stroke patients with strength >2 on manual muscle testing. Exclusion Criteria: item - Any Gait impairment . - Patients with comorbidities like cardiac pathologies. - Patients with dementia . - History of fall in last 6 months. - History of Severe Freezing episodes. - History of Camptocormia (axial deformity. - Central or peripheral paresis.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dual tasking
Dual-task training is an emerging task-specific intervention that aims to improve reactive balance control after destabilizing perturbations in a safe and controlled environment. Dual tasking is given by therapist in unexpected directions to challenge patients reactive balance. In this study dual tasking will be given manually and on hurdles. Daily 45 mins of exercise sessions of dual-task training like walking with talking , walking with a filled cup of water, walking with looking on clock performed for total eight weeks and 5 days a week.
PNF(proprioceptive neuromuscular facilitation exercises)
PNF involves both stretching and contracting (activation) of the muscle group being targeted in order to achieve maximum static flexibility, along with its D1&D2 flexion/extension patterns to improve dynamic flexibility and thus improving balance and coordination. total 8 weeks session will be given to patients. 45 mins session/each day for 5 days a week.

Locations

Country Name City State
Pakistan CIVIL Hospital Bahawalpur Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

Belas Dos Santos M, Barros de Oliveira C, Dos Santos A, Garabello Pires C, Dylewski V, Arida RM. A Comparative Study of Conventional Physiotherapy versus Robot-Assisted Gait Training Associated to Physiotherapy in Individuals with Ataxia after Stroke. Behav Neurol. 2018 Feb 20;2018:2892065. doi: 10.1155/2018/2892065. eCollection 2018. — View Citation

Bergmann J, Krewer C, Muller F, Jahn K. A new cutoff score for the Burke Lateropulsion Scale improves validity in the classification of pusher behavior in subactue stroke patients. Gait Posture. 2019 Feb;68:514-517. doi: 10.1016/j.gaitpost.2018.12.034. Epub 2018 Dec 26. — View Citation

Hernandez ED, Forero SM, Galeano CP, Barbosa NE, Sunnerhagen KS, Alt Murphy M. Intra- and inter-rater reliability of Fugl-Meyer Assessment of Lower Extremity early after stroke. Braz J Phys Ther. 2021 Nov-Dec;25(6):709-718. doi: 10.1016/j.bjpt.2020.12.002. Epub 2020 Dec 17. — View Citation

Kuriakose D, Xiao Z. Pathophysiology and Treatment of Stroke: Present Status and Future Perspectives. Int J Mol Sci. 2020 Oct 15;21(20):7609. doi: 10.3390/ijms21207609. — View Citation

Nguyen PT, Chou LW, Hsieh YL. Proprioceptive Neuromuscular Facilitation-Based Physical Therapy on the Improvement of Balance and Gait in Patients with Chronic Stroke: A Systematic Review and Meta-Analysis. Life (Basel). 2022 Jun 13;12(6):882. doi: 10.3390/life12060882. — View Citation

Villepinte C, Catella E, Martin M, Hidalgo S, Techene S, Lebely C, Castel-Lacanal E, de Boissezon X, Chih H, Gasq D. Validation of French upper limb Erasmus modified Nottingham Sensory Assessment in stroke. Ann Phys Rehabil Med. 2019 Jan;62(1):35-42. doi: 10.1016/j.rehab.2018.03.004. Epub 2018 Apr 13. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Berg balance scale Berg balance scale is used to find and access the balance issues. This scale consists of 14 task which related to everyday life. Each function rates from 0 (worst) to 4 (best) along a dependence and independence sequence. In this test, we gradually reduce the base of support from sitting and standing to single-leg stance, assess a subject's capacity to sustain positions or movements of increasing difficulty. One's ability to change position is also evaluated( 8th week
Primary Montreal Cognitive Assessment (MoCA) Scale MoCA scale is used to meaured cognition .Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform,
1=performs partially and 2=performs fully. The total possible scale score is 226.
8th week
Primary Fugal meyer assessment scale The Fugl-Meyer Assessment of Lower Extremity (FMA-LE) is a widely used and recommended scale for evaluation of post-stroke motor impairment. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
The scale is comprised of five domains and there are 155 items in total
8th week
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