Gastrocinemius Function Massage on Lower Extemity Spasticity (Spasticity)

Effects of Gastrocinemius Function Massage on Lower Extemity Spasticity, Spatio- Temporal Gait Variables and Fall Risk ın Patients With Stroke

This study aimed to investigate gastrocinemius function massage on physical parameters of stroke patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke; Stroke Ischemic
• Intervention / Treatment: Other: Gastrocinemius Function Massage; Other: Sham application

Detailed Description

Gastrocinemius function massage is known to relieve pain and increase range of motion. However, its effects on spasticity and physical performance in stroke patients are not fully understood. In this study, we aimed to investigate the effects of gastrocinemius function massage.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Muş Alparslan University
    • Denizli, Muş Alparslan University, Turkey, 20100
      • University Address

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• having experienced a stroke at least 6 months prior,
• being able to stand independently for at least 1 minute,
• scoring at least 23 on the Standardised Mini-Mental State Examination (SMMSE), indicating no significant cognitive impairment , and
• having lower extremity spasticity rated between 1-3 on the modified Asworth scale
• at least 18 years of age.

Exclusion Criteria:

• comorbidities such as neurological, orthopaedic, metabolic, and rheumatological diseases that could potentially impact soft tissues.
• patients who had received spasticity or other treatments that could affect soft tissues within the past 3 months,
• those with lower extremity injuries, and those with a diagnosis of cancer or who were pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Who received 10 minutes gastrocinemius function massage and 45 minutes classic physiotherapy exercise	Other: Gastrocinemius Function Massage; The purpose of gastrocnemius massage is to alleviate muscle stiffness in the gastrocnemius muscle and enhance mobility in the foot and ankle of the individuals involved. During the GFM application, the patient assumes a prone posture on a suitable treatment bed. The therapist positions themselves behind the patient's side and secures the patient's foot between their hip and ilium.The therapist firmly holds the gastrocnemius muscle using both hands and applies pressure to the ankle, causing it to move in the direction of dorsiflexion. Simultaneously, the therapist applies mobilisation in the cranial direction, following the same path as the gastrocnemius muscle fibres, using both hands. Afterwards, the therapist gently pulls the arm and trunk backwards until the foot and gastrocnemius muscle become relaxed. The application is sustained in a rhythmic manner . We will apply this massage aproximately 10 min to experimental group.
Sham Comparator: Control group; Who received 10 sham applicaiton massage and 45 minutes classic physiotherapy exercise	Other: Sham application; The sham application was conducted when the patient was lying face down, with the hands placed on the gastrocnemius muscle without any movement. We will apply this application aproximately 10 min to experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spasticity	Modified Aswort Scale is used to asses spasticity level of participants,The Muscle Assessment Scale (MAS) is a method utilised to assess the degree of resistance experienced during passive range of motion exercises. This evaluation does not necessitate any specialised equipment and can be conducted swiftly (Bohannon and Smith, 1987). The assessment of the efficacy of pharmacological and rehabilitative therapies in the treatment and management of spasticity in stroke patients is commonly employed (Ansasri et al., 2008). The scale is denoted by the subsequent numerical values (Ansasri et all., 2008). 0: Absence of increase in muscular tone 1: There is a little rise in muscle tension, accompanied by a mild resistance or moderate challenge at the furthest point of movement when flexing or extending the affected body part(s). 1+: A slight augmentation in muscular tension is succeeded by negligible opposition throughout the remaining (less than 50%) of the motion range.	aproximately 10 miutes
Gait parameters and fall risk	Spatial Temporal Gait Analysis, also known as Legsystm, is a method used to analyse the movement patterns and timing of an individual's gait. The walking variables of the subjects were assessed using a wearable walking analysis device known as Legsystm. The user's text is empty. The data gathered by two sensors affixed to the supramaleo region using Velcro is transmitted and processed to the connected computer using Bluetooth. Legsystm possesses the capacity to perform diverse measurements of spatio-temporal data obtained from people. During the Legsystm analysis, participants were instructed to perform the Time up and go test. The Timed Up and Go (TUG) test will be utilised to evaluate the spatio-temporal parameters and ascertain the likelihood of falling in stroke patients. During the TUG (Timed Up and Go) test, the patient is initially positioned in an appropriate chair.	aproximately 5 miutes

Collaborators and Investigators

• Sponsor: Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: February 11, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Spacticity, Gastrocinemius function massage, stroke, gait
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: Gastrocimemius spasticity; E-60116787-020-474196 (Registry Identifier: Pamukkale University Ethics Comitee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No