Balance Performance in Dual Task in Patients With Cervical Disc Herniation Related Chronic Neck Pain:a Comparative Study
1 other identifier
observational
55
1 country
1
Brief Summary
Intense pain and moderate disability are seen most patients with symptomatic cervical disc herniation (CDH). Since neck motion and motor control are associated with changes in neck pain and disability, it is highly likely that patients with neck pain related disability would display dual-task interference (DTI) during postural control with a cognitive task. It is very important for patients with cervical disk herniation to perform more than one task at the same time for many activities of daily living. Therefore, the aim of this study was to compare balance performance in dual task between patients with CDH related chronic neck pain and asymptomatic controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2022
CompletedFirst Submitted
Initial submission to the registry
April 5, 2022
CompletedFirst Posted
Study publicly available on registry
April 21, 2022
CompletedJuly 20, 2022
July 1, 2022
9 months
April 5, 2022
July 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Balance
The Biodex Balance System (BBS; Biodex Medical Systems, Shirley, New York, USA) was used to assess postural control.The evaluated parameters of this system are presented below:The modified clinical test of sensory integration of balance (mCTSIB), athletic single leg test (ASLT), limits of stability (LOS), and fall risk assessment were performed with and without a cognitive task.
Baseline
The modified Clinical Test of Sensory Integration of Balance (mCTSIB)
The mCTSIB was used to assess individuals capability to use sensory inputs for balance.
Baseline
Athletic Single Leg Test (ASLT)
The evaluation was made with eyes open and closed on one leg (dominant limb) on a firm floor on the balance device platform
Baseline
Limits of Stability (LOS):
This test is the best test that measures dynamic control among the standard sway tests.
Baseline
Fall risk assessment
The pre-test platform level was adjusted so that the starting position was 12 and the ending position was 8
Baseline
Secondary Outcomes (1)
Disability level
Baseline
Study Arms (2)
Patient Group
Thirty-two 32 patients with cervical disk herniation related chronic neck pain participated in this cross-sectional controlled study. Patients who aged 18-64 years, had neck pain for at least 12 weeks, no tumor, trauma, fracture pathology in the spinal region and no history of spine surgery were included. The Neck Disability Index (NDI) was used to assess neck pain related disability. The Biodex Balance System (BBS; Biodex Medical Systems, Shirley, New York, USA) was used to assess postural control. The evaluated parameters of this system are presented below: modified clinical test of sensory integration of balance (mCTSIB), athletic single leg test (ASLT), limits of stability (LOS), and fall risk assessment were performed with and without a cognitive task. Dual-task interference (DTI) was assessed.
Control Group
Twenty-three 23 age and sex-matched asymptomatic controls participated in this cross-sectional controlled study. The Biodex Balance System (BBS; Biodex Medical Systems, Shirley, New York, USA) was used to assess postural control.The evaluated parameters of this system are presented below: modified clinical test of sensory integration of balance (mCTSIB), athletic single leg test (ASLT), limits of stability (LOS), and fall risk assessment were performed with and without a cognitive task. Dual-task interference (DTI)was assessed.
Interventions
The Neck Disability Index (NDI) was used to assess neck pain related disability. The Biodex Balance System was used to assess postural control.Clinical test of sensory integration of balance (mCTSIB), athletic single leg test (ASLT), limits of stability (LOS), and fall risk assessment were performed with and without a cognitive task.In order to avoid the order bias of postural control measurements during "Single-task" and "Dual-task" for each case, the order of the measurements was determined by randomization on the first day by using sealed envelope method. After single/double task randomization was made, the order of tests was also randomized by using sealed envelopes containing two different orders (1-mCTSIB, 2-ASLT, 3-Fall test, 4-LOS and 1- LOS, 2- Fall test, 3- ASLT, 4-mCTSIB).
Eligibility Criteria
Between the ages of 18-64 men and women.
You may qualify if:
- to 64 years of age 2.Having generalized neck pain for more than 3 months 3.Being literate and cooperative 4.Being volunteer 5.Volunteer patients diagnosed with chronic neck pain by a specialist
- Asymptomatic individuals between the ages of 18-64
- Without any known disease diagnosis and health problems that would affect the evaluations
You may not qualify if:
- Being pregnant,
- Malignancy,
- Having cervical stenosis,
- Severe cervical spondylosis,
- Cervical fractures and tumor,
- Osteoporosis,
- Neurologic deficit related to compression of the spinal root or cord,
- Having neurologic, dermatologic, infectious, inflammatory rheumatologic and endocrine diseases,
- Any problems that will hinder exercise (advanced cardiopulmonary or orthopedic problems), having intervention including exercise program or physiotherapy in the three months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hayriye Yılmaz
Izmir, 35110, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mehmet G KARAKAYA, Prof, PT
Muğla Sıtkı Koçman University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2022
First Posted
April 21, 2022
Study Start
May 20, 2019
Primary Completion
February 1, 2020
Study Completion
March 20, 2022
Last Updated
July 20, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share