Effect of Stabilization Exercises in Individuals With Non-Specific Chronic Neck Pain.

NCT05369260 | Completed

• 1 other identifier: GOA-5309
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the effects of an 8-week telerehabilitation-based stabilization training in persons with chronic non-specific neck pain will be investigated.

Conditions

Neck Pain

Keywords

Chronic Non-Spesific Neck Pain; Telerehabilitation; Gait; Balance

Outcome Measures

Primary Outcomes (9)

• Speed

  The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess gait speed (m/sec) during usual walking condition and fast walking condition through a Bluetooth®3.0 connection (G-Studio®software).

  Change from Baseline at 8 weeks

• Cadence

  The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess cadence (steps/min) during the usual walking condition and fast walking condition through a Bluetooth®3.0 connection (G-Studio®software).

  Change from Baseline at 8 weeks

• Stride length

  The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess stride length (m) during the usual walking condition and fast walking condition through a Bluetooth®3.0 connection (G-Studio®software).

  Change from Baseline at 8 weeks

• Step lenght

  The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess step length (% stride length) during in usual walking condition and fast walking condition through a Bluetooth®3.0 connection (G-Studio®software).

  Change from Baseline at 8 weeks

• Gait Symmetry

  The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess gait symmetry. Gait symmetry index of the right and left sides are obtained during walking. The score is calculated by the device as a percentage score out of 100. The higher score indicates more symmetrical gait.

  Change from Baseline at 8 weeks

• Pelvic angles

  The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess pelvic movements (tilt (°), obliquity(°), rotation(°)) during gait through a Bluetooth®3.0 connection (G-Studio®software). The device provides the data for these pelvic angles in one single report.

  Change from Baseline at 8 weeks

• Pelvic symmetry

  The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess pelvic symmetry (%) during gait through a Bluetooth®3.0 connection (G-Studio®software). The score is calculated by the device as a percentage score out of 100. The higher score indicates more pelvic symmetry.

  Change from Baseline at 8 weeks

• Postural stability

  A computerized test of the Biodex Balance System will be used to assess postural stability. Subjects will stand on the platform and try to maintain their stability while trying to control their center of pressure which is shown as a point on the screen. The postural stability test assesses the patient's ability to control static balance on a stable platform. The test protocol is performed for 20 seconds with 3 trials. The mean value of the trials is taken as a score. Higher stability index score indicates poor balance and stability.

  Change from Baseline at 8 weeks

• Limits of stability

  A computerized test of limits of stability will be performed using Biodex Balance System®. Subjects will stand on a stable platform and try to maintain their balance while trying to reach in different directions spot that is shown on the screen. The test results present scores for all directions. Higher scores show better performance (0= worst performance; 100= perfect performance).

  Change from Baseline at 8 weeks

Secondary Outcomes (3)

• Neck Disability Index

  Change from Baseline at 8 weeks

• Visual Analog Scale (VAS)

  Change from Baseline at 8 weeks

• Beck Depression Inventory

  Change from Baseline at 8 weeks

Study Arms (2)

Cervical and scapular stabilization group

EXPERIMENTAL

In this arm cervical and scapular stabilization exercises will be applied based on the telerehabilitation method via videoconference for 8 weeks, one day a week , 45-60 minutes for each session.

Other: Telerehabilitation-based cervical and scapular stabilization exercises

Cervical and core stabilization group

EXPERIMENTAL

In this arm cervical and core stabilization exercises will be applied based on the telerehabilitation method via videoconference for 8 weeks, one day a week , 45-60 minutes for each session.

Other: Telerehabilitation-based cervical and core stabilization exercises

Interventions

Telerehabilitation-based cervical and scapular stabilization exercises OTHER

Telerehabilitation based cervical and scapular stabilization exercises will be applied via videoconference method for 8 weeks, one day a week , 45-60 minutes for each session.

Cervical and scapular stabilization group

Telerehabilitation-based cervical and core stabilization exercises OTHER

Telerehabilitation based cervical and core stabilization exercises will be applied via videoconference method for 8 weeks, one day a week , 45-60 minutes for each session.

Cervical and core stabilization group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having non-specific neck pain for at least 3 months
• Having a Neck Disability Index (BDI) score of 10 and above,

You may not qualify if:

• Receiving physiotherapy for neck pain in the last 6 months
• Having speech and comprehension problems,
• Those who have undergone neck surgery
• Those with sensory loss
• Those diagnosed with orthopedic, neurological or vestibular disease
• Those with a history of trauma ( wiplash)
• Cases diagnosed with cancer, osteoporosis or treated will not be included in the study.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead
• Dokuz Eylul University: collaborator

Study Sites (1)

School of Physical Therapy and Rehabilitation, Dokuz Eylül University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hatice Ayan, MSc

  Izmir Katip Celebi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 11, 2022
• Study Start: May 11, 2022
• Primary Completion: August 30, 2022
• Study Completion: October 1, 2022
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

TU (1)