NCT07013942

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 12, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 2, 2025

Last Update Submit

June 9, 2025

Conditions

Keywords

Spasticitystrokedry needlingfunctional performanceEMGFugl meyerModified Ashworth scale

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    6 weeks

Study Arms (2)

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

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

Procedure: Sham Needling Group

Interventions

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.

Dry 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

Sham needling group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Muscle SpasticityStroke

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2025

First Posted

June 10, 2025

Study Start

September 12, 2024

Primary Completion

March 15, 2025

Study Completion

April 15, 2025

Last Updated

June 10, 2025

Record last verified: 2025-06

Locations