- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07013942
- Original Trial
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
30
Phase
- 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
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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
|
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
|
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
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
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)
September 12, 2024
Primary Completion (Actual)
March 15, 2025
Study Completion (Actual)
April 15, 2025
Study Registration Dates
First Submitted
June 2, 2025
First Submitted That Met QC Criteria
June 9, 2025
First Posted (Actual)
June 10, 2025
Study Record Updates
Last Update Posted (Actual)
June 10, 2025
Last Update Submitted That Met QC Criteria
June 9, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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