The Effects of Connective Tissue Manipulation on Balance and Proprioception

NCT04561726 | Completed

• 1 other identifier: 37068608-6100-15-1477
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Connective tissue massage; Connective Tissue Manipulation; Proprioception; Postural Balance

Outcome Measures

Primary Outcomes (1)

• Biodex Balance System (BBS)

  The BBS, which consists of a monitor connected multi-axis platform, objectively measures static and dynamic balance and records measurement results as degrees for three directions: medial lateral stability index, anterior-posterior stability index, and overall stability index. These indices show the fluctuations around the zero point. The mobility of the platform can be adjusted allowing the static and dynamic balance to be measured. Postural Stability Protocol has been selected from 5 test protocols of BBS. In this protocol, the aim is to try to match the ball seen on the screen to the midpoint of the ring shaped screen by transferring the weight on the platform. Firstly, static platform were used and volunteers stand on both foot, then on right and left foot. Then, the same measurements were repeated on dynamic platform which is level 4 out of 8. Each measurement was tested in 3 repetitions. Mean of these repetitions were noted as the score of that measurement.

  10 minutes

Secondary Outcomes (3)

• Cervical Range of Motion Tester (C-ROM)

  10 minutes

• Stabilizer Pressure Biofeedback Unit (SPBU)

  5 minutes

• M3 Comfort Digital Blood Pressure Monitor

  2 minutes

Study Arms (2)

Study Group

EXPERIMENTAL

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.

Other: Connective Tissue Manipulation; Other: Exercise

Exercise Group

ACTIVE COMPARATOR

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.

Other: Exercise

Interventions

Connective Tissue Manipulation 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.

Also known as: Connective Tissue Massage

Study Group

Exercise 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; Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Bahçeşehir University: collaborator
• Yeditepe University: collaborator

Study Sites (1)

Yeditepe University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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).

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 24, 2020
• Study Start: April 2, 2018
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: September 24, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)