Clinical trial NCT04561726: The Effects of Connective Tissue Manipulation on Balance and Proprioception
Official title: The Effects of Connective Tissue Manipulation on Balance and Proprioception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Connective tissue massage
Connective Tissue Manipulation
Proprioception
Postural Balance
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Bahçeşehir University
name: Yeditepe University
First posted: 2020-09-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Biodex Balance System (BBS)
timeFrame: 10 minutes
Secondary outcomes:
measure: Cervical Range of Motion Tester (C-ROM)
timeFrame: 10 minutes
measure: Stabilizer Pressure Biofeedback Unit (SPBU)
timeFrame: 5 minutes
measure: M3 Comfort Digital Blood Pressure Monitor
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University
Study officials:
References: