NCT06760793

Brief Summary

The aim of this clinical trial is to determine whether deep friction massage and stretching reduce muscle contraction in the calf muscle. The primary questions it seeks to answer are:

  • Does deep friction massage or stretching reduce muscle contraction?
  • Does deep friction massage or stretching improve walking?
  • Does deep friction massage or stretching increase ankle joint range of motion? Participants: Participants will undergo either deep friction massage or stretching exercises for 10 minutes, three days a week, over a period of six weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

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 23, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

1.2 years

First QC Date

December 30, 2024

Last Update Submit

January 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Modified Ashworth Scale

    The Modified Ashworth Scale (MAS) is the most widely used clinical scale for measuring increases in muscle tone. The original Ashworth Scale was a 5-point numerical scale that graded spasticity from 0 to 4, with 0 indicating no resistance and 4 indicating a limb that is rigid in flexion or extension.

    before intervention and after 6 weeks

Secondary Outcomes (3)

  • The Modified Tardieu Scale

    Before intervention and after 6 weeks

  • Range of motion (ROM)

    Before intervention and after 6 weeks

  • The Modified Timed Up and Go Test (TUG)

    Before intervention and after 6 weeks

Study Arms (2)

Group 1

EXPERIMENTAL
Other: manual static stretching exercises on plantar flexors

Group 2

EXPERIMENTAL
Other: deep friction massage on plantar flexors

Interventions

A manual static stretching exercises was performed on the plantar flexors in both knee extension and flexion. The stretch was applied while the participant was in a prone position

Group 1

Deep Friction Massage was applied to both the gastrocnemius muscle and the Achilles tendon. Participants were positioned in a prone posture for both applications

Group 2

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • a diagnosis of spastic diplegic or hemiparetic CP
  • aged between 3 and 18 years
  • classified as level I, II, or III according to the Gross Motor Function Classification System (GMFCS)
  • possessing sufficient cognitive function to cooperate.

You may not qualify if:

  • Botulinum toxin (BoNT) injections to the lower extremity muscles within the last six months
  • undergoing any surgery such as muscle lengthening or joint contracture within the last six months
  • non-participation in two consecutive exercise sessions
  • experiencing illnesses such as infections or musculoskeletal injuries during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mugla Sitki Kocman University

Muğla, Menteşe, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 30, 2024

First Posted

January 7, 2025

Study Start

February 23, 2023

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

January 8, 2025

Record last verified: 2025-01

Locations