NCT05931172

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2023

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

8 months

First QC Date

June 26, 2023

Last Update Submit

July 31, 2023

Conditions

Keywords

chronic strokePNFDual taskHemiplegia

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Dual tasking

EXPERIMENTAL

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.

Other: Dual tasking

Proprioceptive neuromuscular facilitation

EXPERIMENTAL

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

Other: PNF(proprioceptive neuromuscular facilitation exercises)

Interventions

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.

Dual tasking

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.

Proprioceptive neuromuscular facilitation

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIVIL Hospital

Chak Four Hundred Fifty-four, Punjab Province, 63100, Pakistan

RECRUITING

Related Publications (6)

  • 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.

    PMID: 33076218BACKGROUND
  • 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.

    PMID: 35743913BACKGROUND
  • 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.

    PMID: 29675114BACKGROUND
  • 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.

    PMID: 33358073BACKGROUND
  • 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.

    PMID: 29660413BACKGROUND
  • 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.

    PMID: 30623845BACKGROUND

MeSH Terms

Conditions

StrokeHemiplegia

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • hira jabeen

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 5, 2023

Study Start

February 25, 2023

Primary Completion

October 18, 2023

Study Completion

October 30, 2023

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations