Working…
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

Tracking Information
First Submitted Date June 27, 2019
First Posted Date July 5, 2019
Last Update Posted Date September 14, 2020
Actual Study Start Date April 6, 2019
Actual Primary Completion Date July 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 3, 2019)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 3, 2019)
  • Sagittal spinal alignment [ Time Frame: 6 months ]
    Alignment of the spine in the sagittal plane measured by a surface topography method
  • 2 minute walk test [ Time Frame: 6 weeks and 6 months ]
    Distance walked in 2 minutes to measure exercise capacity
  • Gait analysis [ Time Frame: 6 weeks and 6 months ]
    Spatiotemoral gait parameters measured using inertial measurement units
  • Tragus to wall distance [ Time Frame: 6 weeks and 6 months ]
    Forward posture measurement using the distance from the ear to the wall
  • Four Square Step Test [ Time Frame: 6 weeks and 6 months ]
    Dynamic balance test involving multidirectional stepping over obstacles
  • Timed loaded standing test [ Time Frame: 6 weeks and 6 months ]
    Measurement of back extensor muscle strength and endurance
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Walking and Balance Related to Sagittal Spinal Posture Alignment
Official Title WiSPA: Walking and Balance Related to Sagittal Spinal Posture and Alignment
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults with a degenerative spinal condition who have been referred to outpatient physiotherapy treatment.
Condition
  • Hyperkyphosis
  • Walking, Difficulty
  • Balance; Distorted
  • Spinal Disease
  • Osteoporosis
  • Spine Degeneration
Intervention Other: Therapeutic exercise class
Physiotherapy exercise class includes education, stretching, strengthening, posture and balance interventions.
Study Groups/Cohorts 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.
Intervention: Other: Therapeutic exercise class
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: July 9, 2020)
41
Original Estimated Enrollment
 (submitted: July 3, 2019)
45
Actual Study Completion Date August 18, 2020
Actual Primary Completion Date July 12, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04008459
Other Study ID Numbers 14031
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University of Oxford
Study Sponsor University of Oxford
Collaborators Not Provided
Investigators
Principal Investigator: Erin Hannink, DPT University of Oxford
PRS Account University of Oxford
Verification Date July 2020