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StrokeNCT05931172

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

A study testing Dual tasking and PNF(proprioceptive neuromuscular facilitation exercises) in people with Stroke, run by Riphah International University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 50 to 70 years
Conditions the study is for
Stroke
What is being tested?
Dual tasking and PNF(proprioceptive neuromuscular facilitation exercises)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 sitePakistan
Study dates
25 Feb 2023to 30 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Imran Amjad contact

03324390125

mran.amjad@riphah.edu.pk

Pakistan1 site, 1 recruiting

  • CIVIL Hospital

    Chak Eighty-seven -Twelve Left, Punjab Province, 63100

    Hira Jabeen, 03234116506, hira.jabeen@riphah.edu.pk

    Nadia Alam, MSNMPT

    Recruiting

Other trials in Pakistan

About this study

Official title: Comparative Effects of Dual Task and Proprioceptive Neuromuscular Facilitation on Balance ,Cognition and Motor Function in Chronic Stroke Patients

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.

Read the 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.

Conditions
Stroke
Being tested
Dual tasking, PNF(proprioceptive neuromuscular facilitation exercises)
Keywords
chronic stroke, PNF, Dual task, Hemiplegia
Medical subject headings
Stroke, Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dual taskingOther

    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)Other

    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.

Study groups in NCT05931172
Study groupRoleWhat they receive
Dual taskingExperimentalDual tasking utilizes a task-specific approach to balance training, applying repeated exposure to unpredictable mechanical perturbations that mimic balance disturbances experienced in daily life.
Receives: Other: Dual tasking
Proprioceptive neuromuscular facilitationExperimentalProprioceptive neuromuscular facilitation (PNF) is a therapeutic approach that uses cutaneous, proprioceptive and auditory input to produce functional improvement in motor output.
Receives: Other: PNF(proprioceptive neuromuscular facilitation exercises)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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(

    Measured: 8th week

  2. 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.

    Measured: 8th week

  3. 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

    Measured: 8th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2023
  2. Study start25 Feb 2023
  3. Primary completion18 Oct 2023 (estimated)
  4. Study completion30 Oct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05931172
Sponsor's protocol ID
REC/LHR/23/0224 nadia
Status last verified
Jul 2023
First submitted
26 Jun 2023
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33076218

  • 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.

    PubMed 35743913

  • 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.

    PubMed 29675114

  • 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.

    PubMed 33358073

  • 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.

    PubMed 29660413

  • 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.

    PubMed 30623845

Questions about this trial

What is this clinical trial studying?

A study testing Dual tasking and PNF(proprioceptive neuromuscular facilitation exercises) in people with Stroke, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Imran Amjad (03324390125, mran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Berg balance scale (time frame: 8th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05931172, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.

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