NCT07171788

Brief Summary

this study will be conducted to investigate the effect of low level laser therapy (LLLT) on wrist flexors spasticity and hand functions in patient with stroke

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable stroke

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

September 6, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

September 6, 2025

Last Update Submit

September 6, 2025

Conditions

Keywords

low level laser therapywrist flexor spasticityhand functionstroke

Outcome Measures

Primary Outcomes (3)

  • spasticity

    Modified ashworth scale will be used to assess spaticity according the following criteria,0: No increase in muscle tone 1. Slight increase in muscle tone, with a catch and release or minimal resistance at the end of the range of motion when an affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested as a catch, followed by minimal resistance through the remainder (less than half) of the range of motion 2. A marked increase in muscle tone throughout most of the range of motion, but affected part(s) are still easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension

    up to 6 weeks

  • hand grip strength

    hand held dynamometer will be used to assess hand grip strength

    up to 6 weeks

  • muscle stiffness

    The MyotonPRO will be used to assess muscle stiffness. it is a new handheld device that conveniently assesses stiffness of muscles and tendons.the device effectively measures changes in muscle stiffness due to fatigue It is placed on the skin over the muscle. A brief, gentle tap from the probe causes the muscle to oscillate. The oscillations are analysed automatically by the device to calculate the muscle's mechanical characteristics, such as its tone, stiffness and how elastic it is.

    up to 6 weeks

Secondary Outcomes (1)

  • pain intensity

    up to 6 weeks

Study Arms (2)

low level laser therapy

EXPERIMENTAL

twenty patients will receive low level laser therapy three times a week for 6 weeks

Other: low level laser therapyOther: selected physical therapy program

selected physical therapy program

ACTIVE COMPARATOR

twenty patients will recieve selected physical therapy program plus sham low level therapy three time a weeks for 6 weeks

Other: selected physical therapy program

Interventions

patients will receive LLT. The LLLT system used in the study (ASA LASER M6) delivered 1.0 W in continuous wave at a wave length in the near infrared of 808 nm. The incident power density will be 670 mW/cm2.The probe head will held with light pressure in contact with the skin over the course of median nerve on the dysfunctional limb for 15 minutes. Protective goggles will be used to prevent direct eye contact of the laser beam. plus selected phyiscal therapy program

low level laser therapy

patient will receive standard physical therapy program for wrist flexors spasticity post-stroke typically includes the following components: Passive stretching: Passive static or dynamic stretching of the wrist flexorss is the mainstay to reduce spasticity and Physical therapy exercises in form of specific techniques of proprioceptive facilitation, relaxation techniques, passive and self-passive motions, and proper limb positioning. plus sham low level laser therapy

low level laser therapyselected physical therapy program

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • forty stroke patients with wrist flexors spasticity from both sex will be participate in this study
  • Their age ranges from 45 to 60 years.
  • Patients will be referred by neurological consultants.
  • preserved cognitive system, i.e., ability to respond to verbal stimul
  • Body mass index less than 30.
  • Patients will be diagnosed by clinical and radiological examination.
  • patients with wrist flexors spasticity according to modified ashworth scale score +1 to 2.

You may not qualify if:

  • Patients with contractures, fractures, rigidity, and deformity
  • Patients with cognitive impairments.
  • Patients with visual, auditory impairment affecting their ability to complete tasks.
  • Uncontrolled Diabetic patient.
  • Presence of hypoesthesia and/or hyperesthesia of the involved upper limb.
  • Other major neurological condition (e.g., Spinal cord injury, multiple sclerosis, Epilepsy, Meningitis, and Brain tumor).
  • presence of neoplastic lesions at the site of application

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Central Study Contacts

heba mohamed, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
opaque sealed envelope
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: low level laser therapy and selected phyisical therapy program
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator : heba hassan amin mohamed

Study Record Dates

First Submitted

September 6, 2025

First Posted

September 15, 2025

Study Start

September 15, 2025

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

September 15, 2025

Record last verified: 2025-09