Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04008459
Recruitment Status : Terminated (Recruitment no longer viable as spinal classes were stopped due to the COVID-19 situation.)
First Posted : July 5, 2019
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Hyperkyphosis Walking, Difficulty Balance; Distorted Spinal Disease Osteoporosis Spine Degeneration 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: WiSPA: Walking and Balance Related to Sagittal Spinal Posture and Alignment
Actual Study Start Date : April 6, 2019
Actual Primary Completion Date : July 12, 2020
Actual Study Completion Date : August 18, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in sagittal spinal alignment [ Time Frame: 6 weeks post-baseline ]
    Alignment of the spine in the sagittal plane measured by a surface topography method


Secondary Outcome Measures :
  1. Sagittal spinal alignment [ Time Frame: 6 months ]
    Alignment of the spine in the sagittal plane measured by a surface topography method

  2. 2 minute walk test [ Time Frame: 6 weeks and 6 months ]
    Distance walked in 2 minutes to measure exercise capacity

  3. Gait analysis [ Time Frame: 6 weeks and 6 months ]
    Spatiotemoral gait parameters measured using inertial measurement units

  4. Tragus to wall distance [ Time Frame: 6 weeks and 6 months ]
    Forward posture measurement using the distance from the ear to the wall

  5. Four Square Step Test [ Time Frame: 6 weeks and 6 months ]
    Dynamic balance test involving multidirectional stepping over obstacles

  6. Timed loaded standing test [ Time Frame: 6 weeks and 6 months ]
    Measurement of back extensor muscle strength and endurance

  7. 36-item Short Form Health Survey (SF-36) [ Time Frame: 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.

  8. Visual analogue pain scale [ Time Frame: 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.

  9. Activities-specific Balance Confidence Scale [ Time Frame: 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.

  10. Modified gait efficacy scale [ Time Frame: 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.

  11. Sagittal spinal alignment [ Time Frame: Within 2 weeks of baseline ]
    Reliability re-test of alignment of the spine in the sagittal plane measured by a surface topography method



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with a degenerative spinal condition who have been referred to outpatient physiotherapy treatment.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04008459


Locations
Layout table for location information
United Kingdom
Nuffield Orthopaedic Centre
Oxford, Oxon, United Kingdom, OX4 1TH
Sponsors and Collaborators
University of Oxford
Investigators
Layout table for investigator information
Principal Investigator: Erin Hannink, DPT University of Oxford
Layout table for additonal information
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT04008459    
Other Study ID Numbers: 14031
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis
Spinal Diseases
Mobility Limitation
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases