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Comparative Effects of Dual Task and PNF on Balance ,Cognition and Motor Function in Chronic Stroke Patients .

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Dual tasking
PNF(proprioceptive neuromuscular facilitation exercises)
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring chronic stroke, PNF, Dual task, Hemiplegia

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CIVIL HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dual tasking

Proprioceptive neuromuscular facilitation

Arm Description

Dual tasking utilizes a task-specific approach to balance training, applying repeated exposure to unpredictable mechanical perturbations that mimic balance disturbances experienced in daily life.

Proprioceptive neuromuscular facilitation (PNF) is a therapeutic approach that uses cutaneous, proprioceptive and auditory input to produce functional improvement in motor output.

Outcomes

Primary Outcome Measures

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(
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.
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

Secondary Outcome Measures

Full Information

First Posted
June 26, 2023
Last Updated
July 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05931172
Brief Title
Comparative Effects of Dual Task and PNF on Balance ,Cognition and Motor Function in Chronic Stroke Patients .
Official Title
Comparative Effects of Dual Task and Proprioceptive Neuromuscular Facilitation on Balance ,Cognition and Motor Function in Chronic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2023 (Actual)
Primary Completion Date
October 18, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (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
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
chronic stroke, PNF, Dual task, Hemiplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dual tasking
Arm Type
Experimental
Arm Description
Dual tasking utilizes a task-specific approach to balance training, applying repeated exposure to unpredictable mechanical perturbations that mimic balance disturbances experienced in daily life.
Arm Title
Proprioceptive neuromuscular facilitation
Arm Type
Experimental
Arm Description
Proprioceptive neuromuscular facilitation (PNF) is a therapeutic approach that uses cutaneous, proprioceptive and auditory input to produce functional improvement in motor output.
Intervention Type
Other
Intervention Name(s)
Dual tasking
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
PNF(proprioceptive neuromuscular facilitation exercises)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Berg balance scale
Description
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(
Time Frame
8th week
Title
Montreal Cognitive Assessment (MoCA) Scale
Description
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.
Time Frame
8th week
Title
Fugal meyer assessment scale
Description
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
Time Frame
8th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad
Phone
03324390125
Email
mran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hira jabeen
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CIVIL Hospital
City
Bahāwalpur
State/Province
Punjab
ZIP/Postal Code
63100
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hira Jabeen
Phone
03234116506
Email
hira.jabeen@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Nadia Alam, MSNMPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33076218
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.
Results Reference
background
PubMed Identifier
35743913
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.
Results Reference
background
PubMed Identifier
29675114
Citation
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.
Results Reference
background
PubMed Identifier
33358073
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.
Results Reference
background
PubMed Identifier
29660413
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.
Results Reference
background
PubMed Identifier
30623845
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.
Results Reference
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Comparative Effects of Dual Task and PNF on Balance ,Cognition and Motor Function in Chronic Stroke Patients .

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