Walking and Balance Related to Sagittal Spinal Posture Alignment (WiSPA)

WiSPA: Walking and Balance Related to Sagittal Spinal Posture and Alignment

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

Study Overview

• Status: Terminated
• Conditions: Osteoporosis; Spine Degeneration; Balance; Distorted; Spinal Disease; Walking, Difficulty; Hyperkyphosis
• Intervention / Treatment: Other: Therapeutic exercise class

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 Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• United Kingdom
  • Oxon
    • Oxford, Oxon, United Kingdom, OX4 1TH
      • Nuffield Orthopaedic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with a degenerative spinal condition who have been referred to outpatient physiotherapy treatment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Degenerative musculoskeletal spinal conditions; Participants are included who are enrolled in a 6-week physiotherapy exercise class aimed at improving function in people with degenerative spinal conditions.	Other: Therapeutic exercise class; Physiotherapy exercise class includes education, stretching, strengthening, posture and balance interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sagittal spinal alignment	Alignment of the spine in the sagittal plane measured by a surface topography method	6 weeks post-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sagittal spinal alignment	Alignment of the spine in the sagittal plane measured by a surface topography method	6 months
2 minute walk test	Distance walked in 2 minutes to measure exercise capacity	6 weeks and 6 months
Gait analysis	Spatiotemoral gait parameters measured using inertial measurement units	6 weeks and 6 months
Tragus to wall distance	Forward posture measurement using the distance from the ear to the wall	6 weeks and 6 months
Four Square Step Test	Dynamic balance test involving multidirectional stepping over obstacles	6 weeks and 6 months
Timed loaded standing test	Measurement of back extensor muscle strength and endurance	6 weeks and 6 months
36-item Short Form Health Survey (SF-36)	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.	6 weeks and 6 months
Visual analogue pain scale	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.	6 weeks and 6 months
Activities-specific Balance Confidence Scale	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.	6 weeks and 6 months
Modified gait efficacy scale	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.	6 weeks and 6 months
Sagittal spinal alignment	Reliability re-test of alignment of the spine in the sagittal plane measured by a surface topography method	Within 2 weeks of baseline

Collaborators and Investigators

• Sponsor: University of Oxford
• Investigators: Principal Investigator: Erin Hannink, DPT, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2019
• Primary Completion (Actual): July 12, 2020
• Study Completion (Actual): August 18, 2020

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 10, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Spinal Curvatures; Bone Diseases, Metabolic; Osteoporosis; Spinal Diseases; Mobility Limitation; Kyphosis
• Other Study ID Numbers: 14031

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No