Gastrocinemius Function Massage on Lower Extemity Spasticity

NCT ID: NCT06265753

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-23

Study Completion Date

2024-09-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Stroke Stroke Ischemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In the study, 2 different groups (experimental and control) will be formed by using randomisation method. In addition to 45 minutes of classical physiotherapy exercises, 10 minutes of gastrocinemius function massage will be applied to the experimental group, while 10 minutes of sham massage and 45 minutes of classical physiotherapy exercises will be applied to the control group. The application will continue 2 days a week for 6 weeks. Spasticity, gait parameters and fall risks of the participants will be evaluated before and after the treatment with the help of various tests.

Translated with www.DeepL.com/Translator (free version)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental Group

Who received 10 minutes gastrocinemius function massage and 45 minutes classic physiotherapy exercise

Group Type EXPERIMENTAL

Gastrocinemius Function Massage

Intervention Type OTHER

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.

Control group

Who received 10 sham applicaiton massage and 45 minutes classic physiotherapy exercise

Group Type SHAM_COMPARATOR

Sham application

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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Emre BASKAN

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Address

Denizli, Muş Alparslan University, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Dengiz A, Sekeroz S, Baskan E, Kara G. Effects of gastrocnemius functional massage on lower extemity spasticity, spatio- temporal gait variables and fall risk in patients with stroke: A randomized controlled trial. PLoS One. 2025 Sep 24;20(9):e0332308. doi: 10.1371/journal.pone.0332308. eCollection 2025.

Reference Type DERIVED
PMID: 40991570 (View on PubMed)

Other Identifiers

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E-60116787-020-474196

Identifier Type: REGISTRY

Identifier Source: secondary_id

Gastrocimemius spasticity

Identifier Type: -

Identifier Source: org_study_id

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