NCT06548321

Brief Summary

This Study will help to explain us that ExtracorporealShockwave therapy can reduce spasticity in Stroke Patient,help them to restore their abilities and ROM.Therapy reduces dependency rate of patient.Also seen this therapy shows reduction in spasticity of CP child population.Improving the motor recovery.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

October 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

August 7, 2024

Last Update Submit

August 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Modified Ashworth Scale MAS

    The Ashworth Scale method of grading spasticity, working with Cerebral Palsy and Stroke patients. The original Ashworth scale was a 5 point numerical scale that graded spasticity from 0 to 4, with 0 being no resistance and 4 being a limb rigid in flexion or extension. In 1987, while performing a study to exam interrater reliability of manual tests of elbow flexor muscle spasticity, Bohannon and Smith modified the Ashworth scale by adding 1+ to the scale to increase sensitivity. Since its modification, the modified Ashworth scale (MAS), has been applied in clinical practice and research as a measure of spasticity.

    12 Months

Study Arms (1)

Extracorporeal Shockwave Therapy

EXPERIMENTAL
Diagnostic Test: Extracorporeal Shockwave Therapy

Interventions

" The ESTW machine is turned on and the instrument, or shockwave gun, is pressed against the affected area. Rapid impulses are then delivered to the patient. Treatment typically lasts between 5 and 15 minutes. While this treatment can be uncomfortable for some, most do not experience any pain. Once treatment is completed, patients should do their best to physical activity… higher levels of energy Shockwaves into deeper tissue locations… ESWT therapies can help treat neurological disorders like multiple sclerosis and the effects of stroke.

Extracorporeal Shockwave Therapy

Eligibility Criteria

Age10 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • rd stage of Stroke

You may not qualify if:

  • Non spastic CP,1st stage of Stroke,Spasticity caused by injury,Newborn

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical setups Sargodha,Lahore,BWN

Lahore, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2024

First Posted

August 12, 2024

Study Start

October 1, 2023

Primary Completion

May 1, 2024

Study Completion

September 30, 2024

Last Updated

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations