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HealthyNCT04561726

The Effects of Connective Tissue Manipulation on Balance and Proprioception

A study testing Connective Tissue Manipulation and Exercise in people with Healthy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Connective Tissue Manipulation and Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Apr 2018to 31 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Yeditepe University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

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
Being tested
Connective Tissue Manipulation, Exercise
Keywords
Connective tissue massage, Connective Tissue Manipulation, Proprioception, Postural Balance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Connective Tissue ManipulationOther

    Also called Connective Tissue Massage

    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.

  • ExerciseOther

    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.

Study groups in NCT04561726
Study groupRoleWhat they receive
Study GroupExperimentalAll 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.
Receives: Other: Connective Tissue Manipulation; Other: Exercise
Exercise GroupActive comparatorAll 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.
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 10 minutes

Secondary outcomes (3)

  1. Cervical Range of Motion Tester (C-ROM)

    It is glasses-shaped measurement device which indicate the position of the head and consist of two inclinometers which are in sagittal and frontal planes.

    To assess cervical proprioception, flexion and right and left lateral flexion were chosen. When they put on the CROM, we asked them to bend the head forward and we stopped them when they reached 30 degrees and asked them to feel the amount of movement and muscle tension. We repeated the procedure 3 times with eyes open and 3 times with eyes closed. Then we asked the volunteers to flex their heads three times and stop when they thought they reached 30 degrees. Average of each flexion degrees that they stopped was noted and the deviation from the target angle was calculated as score.

    Then the same procedure was repeated for right and left lateral flexion.

    Measured: 10 minutes

  2. Stabilizer Pressure Biofeedback Unit (SPBU)

    SPBU consists of three-chamber pressure cell connected to gauge and inflation bulb. It is used for the strengthening of the abdominal and erector muscles or teaching the stabilization exercises. In our study, it was used for to measure the ability of the person to return to the pressure level which is taught before. Volunteers were in hook-lying position. They were asked to perform posterior pelvic tilt and the pressure cell was inflated to 40 mmHg. Then, they were asked to relax. Later, the posterior pelvic tilt was performed 3 times with the eyes open and 3 times with the eyes closed so that the volunteers could feel the amount of contraction in the muscles at 40mmHg. Then the test began. As in the trials, the volunteers perform posterior pelvic tilt with eyes open and eyes closed (3 times each) and said "I feel this is 40mmHg" when they thought they reached 40mmHg. The deviation from the target pressure was calculated and averages of 3 measurements were recorded as score.

    Measured: 5 minutes

  3. M3 Comfort Digital Blood Pressure Monitor

    It is used to measure heart rate and blood pressure. The cuff was placed on the arm in relation to brachial artery. Volunteers were informed about avoiding exercise and not eating or drinking half an hour before blood pressure measurement. It was noted that the clothing was not squeezing the arm. The volunteers were positioned on a chair with back support, both feet on the floor and the upper arm supported at the level of the heart and were asked not to contract any muscle of upper arm.

    Measured: 2 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2020
  2. Study start2 Apr 2018
  3. Primary completion31 Aug 2018
  4. Study completion31 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04561726
Sponsor's protocol ID
37068608-6100-15-1477
Status last verified
Sep 2020
First submitted
22 Sep 2020
Last updated
24 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Connective Tissue Manipulation and Exercise in people with Healthy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biodex Balance System (BBS) (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04561726.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.

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