NCT06856473

Brief Summary

This study investigates the effects of dry needling on spasticity and its impact on functional ability in individuals with neuromuscular disorders. Using the Modified Ashworth Scale (MAS), Timed Up and Go (TUG) test, and Gross Motor Function Measure (GMFM), the research evaluates changes in muscle tone, mobility, and overall motor performance following dry needling intervention. The findings aim to provide evidence on the clinical benefits of dry needling as a therapeutic approach for improving movement efficiency and functional outcomes in patients with spasticity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2025

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

February 23, 2025

Last Update Submit

September 15, 2025

Conditions

Keywords

Dry NeedleSpasticityFunctional abilities

Outcome Measures

Primary Outcomes (1)

  • Modified Ashwarth Scale (MAS)

    The MAS measures spasticity on a 6-point ordinal scale from 0 to 4, with an additional 1+ category. Minimum Value (0): No increase in muscle tone (better outcome). Maximum Value (4): Affected part(s) rigid in flexion or extension (worse outcome). Higher scores indicate greater spasticity, representing a worse outcome.

    Week 12 after intervention completion

Secondary Outcomes (2)

  • Gross Motor Function Measure (GMFM)

    Week 12 after intervention completion.

  • Time up and go test (TUG)

    Week 12 after intervention completion

Study Arms (2)

Traditional physical therapy Group

ACTIVE COMPARATOR

Traditional physical therapy program based on neurodevelopmental treatment (NDT) (3 sessions per week, each lasting 1 hour).

Other: Traditional Physical Therapy

Dry needling Group

EXPERIMENTAL

traditional physical therapy program based on neurodevelopmental Treatment (NDT) (3 sessions per week, each lasting 1 hour), in addition to dry needling for the spastic calf and adductor muscles.

Other: Traditional Physical TherapyOther: Dry Needling

Interventions

Traditional Physical Therapy based on neurodevelopmental technique

Also known as: Conventional physical therapy
Dry needling GroupTraditional physical therapy Group

Dry Needling in addition to the same traditional physical therapy program

Also known as: Study group
Dry needling Group

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertonia score 2 according to MAS
  • Able to understand and follow instructions
  • Able to stand and walk independantly

You may not qualify if:

  • Participants with neurological conditions that involve significant cognitive deficits or severe uncontrolled epilepsy
  • Participants who have undergone surgical procedures within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BMC

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study follows a randomized controlled trial (RCT) design with a parallel-group interventional model to evaluate the effects of dry needling on spasticity and functional outcomes. Participants are randomly assigned to one of two groups: Study Group (Intervention Group): Receives dry needling for the spastic calf and adductor muscles in addition to a traditional physical therapy program based on Neurodevelopmental Treatment (NDT) (3 sessions per week, each lasting 1 hour). Control Group: Receives only the traditional physical therapy program (NDT) without dry needling, following the same frequency and duration.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 23, 2025

First Posted

March 4, 2025

Study Start

February 20, 2025

Primary Completion

June 30, 2025

Study Completion

August 20, 2025

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations