HyperkyphosisWiSPANCT04008459
Walking and Balance Related to Sagittal Spinal Posture Alignment
An observational study of Hyperkyphosis and Walking, Difficulty, run by University of Oxford at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperkyphosis, Walking, Difficulty, Balance; Distorted
- What is being tested?
- Therapeutic exercise class
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Apr 2019to 18 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults with a degenerative spinal condition who have been referred to outpatient physiotherapy treatment.
Who may be able to join
- 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.
Who cannot join
- Participant is unable to stand independently.
- Participant has a neurological condition which alters motor function and/or postural control.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperkyphosis, Walking, Difficulty, Balance; Distorted, Spinal Disease, Osteoporosis, Spine Degeneration
- Being tested
- Therapeutic exercise class
- Medical subject headings
- Kyphosis, Mobility Limitation, Spinal Diseases, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exercise classOther
Physiotherapy exercise class includes education, stretching, strengthening, posture and balance interventions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Therapeutic exercise class |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sagittal spinal alignment
Alignment of the spine in the sagittal plane measured by a surface topography method
Measured: 6 weeks post-baseline
Secondary outcomes (11)
Sagittal spinal alignment
Alignment of the spine in the sagittal plane measured by a surface topography method
Measured: 6 months
2 minute walk test
Distance walked in 2 minutes to measure exercise capacity
Measured: 6 weeks and 6 months
Gait analysis
Spatiotemoral gait parameters measured using inertial measurement units
Measured: 6 weeks and 6 months
Tragus to wall distance
Forward posture measurement using the distance from the ear to the wall
Measured: 6 weeks and 6 months
Four Square Step Test
Dynamic balance test involving multidirectional stepping over obstacles
Measured: 6 weeks and 6 months
Timed loaded standing test
Measurement of back extensor muscle strength and endurance
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Within 2 weeks of baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start6 Apr 2019
- Primary completion12 Jul 2020
- Study completion18 Aug 2020
Why it stopped: Recruitment no longer viable as spinal classes were stopped due to the COVID-19 situation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkyphosisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Hannink, DPT, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008459
- Sponsor's protocol ID
- 14031
- Acronym
- WiSPA
- Status last verified
- Jul 2020
- First submitted
- 27 Jun 2019
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WiSPA: Walking and Balance Related to Sagittal Spinal Posture and Alignment
- ClinicalTrials.gov ID
- NCT04008459
- Acronym / sponsor ID
- WiSPA / 14031
- Conditions
- Hyperkyphosis, Walking, Difficulty, Balance; Distorted, Spinal Disease, Osteoporosis, Spine Degeneration
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment no longer viable as spinal classes were stopped due to the COVID-19 situation.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 6 Apr 2019 (actual)
- Primary completion
- 12 Jul 2020 (actual)
- Study completion
- 18 Aug 2020 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Degenerative musculoskeletal spinal conditions | – | Other: Therapeutic exercise classParticipants are included who are enrolled in a 6-week physiotherapy exercise class aimed at improving function in people with degenerative spinal conditions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults with a degenerative spinal condition who have been referred to outpatient physiotherapy treatment.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Participant is unable to stand independently.
- Participant has a neurological condition which alters motor function and/or postural control.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic exercise classPhysiotherapy exercise class includes education, stretching, strengthening, posture and balance interventions. | Other | Degenerative musculoskeletal spinal conditions |
Primary outcome
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
11 secondary outcomes
Sagittal spinal alignment
Time frame: 6 months
2 minute walk test
Time frame: 6 weeks and 6 months
Gait analysis
Time frame: 6 weeks and 6 months
Tragus to wall distance
Time frame: 6 weeks and 6 months
Four Square Step Test
Time frame: 6 weeks and 6 months
Timed loaded standing test
Time frame: 6 weeks and 6 months
36-item Short Form Health Survey (SF-36)
Time frame: 6 weeks and 6 months
Visual analogue pain scale
Time frame: 6 weeks and 6 months
Activities-specific Balance Confidence Scale
Time frame: 6 weeks and 6 months
Modified gait efficacy scale
Time frame: 6 weeks and 6 months
Sagittal spinal alignment
Time frame: Within 2 weeks of baseline
Results and safety
The study was stopped early (reason given: Recruitment no longer viable as spinal classes were stopped due to the COVID-19 situation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Hannink, DPT principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperkyphosis and Walking, Difficulty, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment no longer viable as spinal classes were stopped due to the COVID-19 situation.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sagittal spinal alignment (time frame: 6 weeks post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.