SpasticityNCT07013942
Additional Effects of Dry Needling With PNF on Spasticity and Functional Performance in Stroke
A study testing Dry Needling Group in people with Spasticity and Dry Needling, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Spasticity, Dry Needling, Functional Performance
- What is being tested?
- Dry Needling Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Sep 2024to 15 Apr 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years to 65 years of age.
- Males and females
- Post stroke spasticity
- Ischemic stroke
Who cannot join
- Non-compliant Diabetic patients
- Active Hypertensive patients
- Immuno compromised patients
- Patients with underlying infections
- Patients with autoimmune diseases
- Patients that have any contagious conditions
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Therapy
Islamabad, 44000
About this study
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.
Read the 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
- Conditions
- Spasticity, Dry Needling, Functional Performance
- Being tested
- Dry Needling Group, Sham Needling Group
- Keywords
- Spasticity, stroke, dry needling, functional performance, EMG, Fugl meyer, Modified Ashworth scale
- Medical subject headings
- Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry Needling GroupProcedure or surgery
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.
Sham Needling GroupProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Dry needling group | Experimental | 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 Receives: Procedure: Dry Needling Group |
| Sham needling group | Experimental | 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 Receives: Procedure: Sham Needling Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spasticity
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
Measured: 6 weeks
Functional Performance
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start12 Sep 2024
- Primary completion15 Mar 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013942
- Sponsor's protocol ID
- FUI/CTR/2025/80
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects of Dry Needling With PNF on Spasticity and Functional Performance in Stroke
- ClinicalTrials.gov ID
- NCT07013942
- Acronym / sponsor ID
- FUI/CTR/2025/80
- Conditions
- Spasticity, Dry Needling, Functional Performance
- Keywords
- Spasticity, stroke, dry needling, functional performance, EMG, Fugl meyer, Modified Ashworth scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling group | Experimental | Procedure: Dry Needling GroupThis 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 |
| Sham needling group | Experimental | Procedure: Sham Needling GroupThis 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years to 65 years of age.
- Males and females
- Post stroke spasticity
- Ischemic stroke
Key exclusion criteria (6 listed)
- Non-compliant Diabetic patients
- Active Hypertensive patients
- Immuno compromised patients
- Patients with underlying infections
- Patients with autoimmune diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry Needling GroupGroup 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. | Procedure or surgery | Dry needling group |
| Sham Needling GroupGroup 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 | Procedure or surgery | Sham needling group |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling Group in people with Spasticity and Dry Needling, run by Foundation University Islamabad 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 10 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spasticity (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2025.