The Effects of Connective Tissue Manipulation on Balance and Proprioception

NCT ID: NCT04561726

Last Updated: 2020-09-24

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-02

Study Completion Date

2018-08-31

Brief Summary

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There are various exercises and manual techniques to improve balance and proprioception. Most of these manual therapy techniques are mobilization, manipulation, post-isometric relaxation, myofascial relaxation and traction massage. At the same time, it has been observed that many parameters such as range of motion, tissue tension, wound healing process and pain perception were examined in the studies in the literature, but the effects of CTM on balance and proprioception have not been investigated.

The aim of the study was to investigate the effects of CTM on balance and proprioception among healthy individuals. 40 volunteers studying in Bahcesehir University were divided into 1) exercise and 2) study (CTM with exercise) groups equally. Both exercise and study groups were instructed to perform home exercises for 2 sessions in a week for 6 weeks (12 sessions in total). Additionally, CTM was applied to the volunteers in study group for 6 weeks, 2 sessions in a week. CTM applied to the lower and the upper back, and also neck.

Balance, cervical and lumbar proprioception was measured to understand the effectiveness of the CTM. Biodex Balance System was used for evaluation of static and dynamic balance. The cervical proprioception was measured by using a cervical range of motion (CROM) device while lumbar proprioception was measured by StabilizerTM Pressure Biofeedback Unit. Additionally, heart rate and blood pressure were measured by M3 Comfort Digital blood Pressure Monitor. All measurements applied at the beginnig and end of the study.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The sample size was calculated before starting to study by the G\*Power 3.1.9.2. In order to find a meaningful difference between the pre-treatment and post-treatment Biodex Balance System (BBS) measurements, study group should include at least 18 individuals when the type I error was 0.5 and 95% power value (1-β = 0.95). Considering the data loss that may occur during the study period, 20 volunteers were planned for each group (40 voluntary university students in total).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
The volunteers were numbered according to the order of their application. At the end of the applications, small papers were numbered from 1 to 40, and among these papers, the first 20 people selected by the lottery method were included in the study group, and the rest were included in the exercise group.

Study Groups

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Study Group

All of the 20 participants in the study group were asked to do the given 11 home exercises (balance, stretching and strengthening exercises) twice a week for 6 weeks. The exercises were progressed day by day. All of the exercises were taught in the first assessment day, after the all measurements collected. All participants were controlled every week by social media and face-to-face conversations.

Additionally, CTM was applied to the volunteers in study group for 6 weeks, 2 sessions in a week.CTM applied to lumbosacral area (basic region), lower toracal, scapular, interscapular and cervical regions, respectively.

Group Type EXPERIMENTAL

Connective Tissue Manipulation

Intervention Type OTHER

Connective tissue manipulation is a soft tissue manipulative technique and also a reflex therapy which is characterized by localised and specific strokes performed in where the fascia is superficial or palpable. A shear force is created between the skin-underlying fascia or dermis-hypodermis and angulatory force is applied to the collagen fibers to produce reflex and mechanical effects.

Exercise

Intervention Type OTHER

The purpose of the given home exercises is to increase motor ability in activities such as standing, walking and posture, to increase muscle strength and also to elongate muscles. Exercises progressed day by day according to the adaptation of the motor system and muscle strength to the exercises.

Exercise Group

All of the 20 participants in the exercise group were asked to do the given 11 home exercises (balance, stretching and strengthening exercises) twice a week for 6 weeks. The exercises were progressed day by day. All of the exercises were taught in the first assessment day, after the all measurements collected. All participants were controlled every week by social media and face-to-face conversations.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

The purpose of the given home exercises is to increase motor ability in activities such as standing, walking and posture, to increase muscle strength and also to elongate muscles. Exercises progressed day by day according to the adaptation of the motor system and muscle strength to the exercises.

Interventions

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Connective Tissue Manipulation

Connective tissue manipulation is a soft tissue manipulative technique and also a reflex therapy which is characterized by localised and specific strokes performed in where the fascia is superficial or palpable. A shear force is created between the skin-underlying fascia or dermis-hypodermis and angulatory force is applied to the collagen fibers to produce reflex and mechanical effects.

Intervention Type OTHER

Exercise

The purpose of the given home exercises is to increase motor ability in activities such as standing, walking and posture, to increase muscle strength and also to elongate muscles. Exercises progressed day by day according to the adaptation of the motor system and muscle strength to the exercises.

Intervention Type OTHER

Other Intervention Names

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Connective Tissue Massage

Eligibility Criteria

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Inclusion Criteria

* Being voluntary
* Being healthy enough not to be constantly under the control of a health institution
* Being over 18 years old

Exclusion Criteria

* Having neurological or orthopedic problems that can influence lower extremity functions and balance,
* Having any kind of vestibular system problems (Vertigo, Meniere etc.)
* Having a surgery from lumbar, thoracic or/and cervical regions.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bahçeşehir University

OTHER

Sponsor Role collaborator

Yeditepe University

OTHER

Sponsor Role collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Çiçek Günday

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yeditepe University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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37068608-6100-15-1477

Identifier Type: -

Identifier Source: org_study_id

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