Additional Effects of Dry Needling With PNF on Spasticity and Functional Performance in Stroke

June 9, 2025 updated by: Foundation University Islamabad
Stroke is a prevalent cause of long-term disability, with a rising global incidence. Stroke patients commonly experience impaired balance and trunk control, which limits their daily activities and quality of life. Spasticity is the result of upper motor neuron lesion in which the reflex arc is spared, however there is a lesion to the descending pathways of the spinal cord, which leads to the hyper excitability of the alpha motor neurons. Spasticity is a form of velocity dependent hypertonia. When dry needle is applied it induces relaxation in the muscle by increasing the distance between the z lines in the sarcomere and reduces the overlapping of contractile proteins, which ultimately leads to relaxation in the muscle. Dry needling also reduces the firing of the afferent pathways from the local muscle to the spinal cord reducing the excitability of the alpha motor neurons this leads to reduce spasticity. A randomized control trial will be conducted in multidisciplinary lab of FUCP, department of physical medicine and rehabilitation of Fauji Foundation Hospital on the sample of 30 participants. The subjects will be randomized into two groups by sealed opaque envelope method. A treatment over the course of 6 weeks will be provided. Interventional group will be receiving dry needling in addition to Proprioceptive Neuromuscular Facilitation while the control group will receive sham needling in addition to Proprioceptive Neuromuscular Facilitation. Exercise training would be done for a total of 6 weeks, with needling twice a week, the session will last 30- 50 minutes. Using SPSS version 21 would do analysis. Ethical approval will be obtained from ERC of FUSH. Informed written consent will be obtained from all participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  • To determine the effects of balance training with and without gaze stability exercises on mobility in older adults with mild cognitive impairment. To determine the additional effects of dry needling with Proprioceptive neuromuscular facilitation in comparison to sham needling with proprioceptive neuromuscular facilitation on spasticity in stroke.
  • To determine the effects of dry needling with Proprioceptive neuromuscular facilitation techniques in comparison to sham needling with proprioceptive neuromuscular facilitation on functional performance in stroke

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 44000
        • Foundation University College of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years to 65 years of age.
  • Males and females
  • Post stroke spasticity
  • Ischemic stroke

Exclusion Criteria:

  • Non-compliant Diabetic patients
  • Active Hypertensive patients
  • Immuno compromised patients
  • Patients with underlying infections
  • Patients with autoimmune diseases
  • Patients that have any contagious conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dry needling group
This group will receive dry needling twice a week along with gait training, functional training. the aim of this is to reduce spasticity with the help of dry needling with will aid in the improvement by increasing the functionality of the affected limb. Dry needling will be performed twice a week along with the exercise program
Procedure: Dry Needling Group
Group A, which will be considered the interventional group. This group will be receiving the dry needling along with the PNF techniques for spasticity and functional performance.
Experimental: Sham needling group
This group focuses on elimination or accounting the placebo effect that may surround the concept of dry needling, this group doesn't really receive dry needling however the illusion is created in addition to the functional training gait training that the patient is receiving, sham needling will be done twice a week along with the exercise program
Procedure: Sham Needling Group
Group B, which will be considered the control group. This group will be receiving sham needling in addition to the PNF techniques for spasticity and the functional performance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Spasticity
Time Frame: 6 weeks
EMG will be used to highlight spasticity. The increased values of the ratio indicates increased hyper excitability of neurons hence indicating higher spasticity and hypertonia. Reduction of this ratio indicates relaxation of the muscles and decreased hyper excitability of the afferent pathway
6 weeks
Functional Performance
Time Frame: 6 weeks
Functional performance will be checked using Fugl meyer. The overall score is 226. Higher scores indicate better functional performances. And lower scores indicate functional limitations
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Foundation University Islamabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 12, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FUI/CTR/2025/80

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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