Walking and Balance Related to Sagittal Spinal Posture Alignment

Osteoporosis Clinical Trial

— WiSPA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04008459
• Other study ID #: 14031
• Status: Terminated
• Start date: April 6, 2019
• Est. completion date: August 18, 2020

Study information

• Verified date: July 2020
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: August 18, 2020
• Est. primary completion date: July 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Balance; Distorted
• Hyperkyphosis
• Mobility Limitation
• Osteoporosis
• Spinal Disease
• Spinal Diseases
• Spine Degeneration
• Walking, Difficulty

Intervention

Other:
• Therapeutic exercise class
Physiotherapy exercise class includes education, stretching, strengthening, posture and balance interventions.

Locations

Country	Name	City	State
United Kingdom	Nuffield Orthopaedic Centre	Oxford	Oxon

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sagittal spinal alignment	Alignment of the spine in the sagittal plane measured by a surface topography method	6 weeks post-baseline
Secondary	Sagittal spinal alignment	Alignment of the spine in the sagittal plane measured by a surface topography method	6 months
Secondary	2 minute walk test	Distance walked in 2 minutes to measure exercise capacity	6 weeks and 6 months
Secondary	Gait analysis	Spatiotemoral gait parameters measured using inertial measurement units	6 weeks and 6 months
Secondary	Tragus to wall distance	Forward posture measurement using the distance from the ear to the wall	6 weeks and 6 months
Secondary	Four Square Step Test	Dynamic balance test involving multidirectional stepping over obstacles	6 weeks and 6 months
Secondary	Timed loaded standing test	Measurement of back extensor muscle strength and endurance	6 weeks and 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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