Walking and Balance Related to Sagittal Spinal Posture Alignment

Terminated

• Conditions: Hyperkyphosis; Spine Degeneration; Spinal Disease; Osteoporosis; Walking, Difficulty; Balance; Distorted
• Interventions: Other: Therapeutic exercise class

• Registration Number: NCT04008459
• Lead Sponsor: University of Oxford

Brief Summary

This study aims to improve understanding of the relationship between spinal alignment and walking and balance in people who have degenerative spinal conditions.

Detailed Description

This prospective cohort study will include people who are attending physiotherapy to address a degenerative spinal condition and measure them longitudinally. The investigators will measure spinal alignment, walking capacity and pattern, dynamic balance, and back muscle strength along with self-reported measures that reflect the person's functional self-efficacy, quality of life, and general health. Physical and self-reported outcome measures will be assessed at baseline before the physiotherapy-led exercise class commences, after completion at 6 weeks, and 6 months post baseline.

Study Timeline

• Study Start: 2019-04-06
• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-05
• Status Verified: 2020-07
• Primary Completion: 2020-07-12
• Study Completion: 2020-08-18
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Participant is diagnosed with a degenerative spinal condition.
• Participant is willing and able to give informed consent for participation in the study.
• Men and women aged 18 years or older.
• Participant is able to understand and participate safely in a physiotherapy measurement assessment.
• Participant is enrolled in physiotherapy.

Exclusion Criteria

• Participant is unable to stand independently.
• Participant has a neurological condition which alters motor function and/or postural control.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Degenerative musculoskeletal spinal conditions	Therapeutic exercise class	Participants are included who are enrolled in a 6-week physiotherapy exercise class aimed at improving function in people with degenerative spinal conditions.

Primary Outcome Measures

Name	Time	Method
Change in sagittal spinal alignment	6 weeks post-baseline	Alignment of the spine in the sagittal plane measured by a surface topography method

Secondary Outcome Measures

Name	Time	Method
Sagittal spinal alignment	Within 2 weeks of baseline	Reliability re-test of alignment of the spine in the sagittal plane measured by a surface topography method
2 minute walk test	6 weeks and 6 months	Distance walked in 2 minutes to measure exercise capacity
Gait analysis	6 weeks and 6 months	Spatiotemoral gait parameters measured using inertial measurement units
Tragus to wall distance	6 weeks and 6 months	Forward posture measurement using the distance from the ear to the wall
36-item Short Form Health Survey (SF-36)	6 weeks and 6 months	Health survey measuring aspects of quality of life. The questionnaire contains 36 questions which form 8 subscales: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Each question is directly transformed into a 0-100 scale with the lower the score the more disability.
Timed loaded standing test	6 weeks and 6 months	Measurement of back extensor muscle strength and endurance
Visual analogue pain scale	6 weeks and 6 months	Measurement of pain in a participant's back. The scale is along a horizontal 10 cm line with markings from 0 to 10, 0 indicating no pain and 10 indicating the worst pain imaginable.
Four Square Step Test	6 weeks and 6 months	Dynamic balance test involving multidirectional stepping over obstacles
Activities-specific Balance Confidence Scale	6 weeks and 6 months	Questionnaire measuring balance confidence in various situations. It contains 16 questions in which participants rate their confidence in performing the activities on a scale from 0-100, 0 representing no confidence and 100 representing complete confidence. The total score is calculated to be on a similar 0 to 100 scale.
Modified gait efficacy scale	6 weeks and 6 months	Questionnaire measuring walking confidence and self-efficacy. Each of the 10 items is scored on a 10-point Likert scale with 1 representing no confidence and 10 representing complete confidence. The total score ranges from 10-100.

Trial Locations

Locations (1)

Nuffield Orthopaedic Centre; 🇬🇧 Oxford, Oxon, United Kingdom