Acquired Brain InjuryNCT04062149
Does Improved Ability to Achieve Single Leg Stance Lead to a More Efficient Gait Pattern in Adults With Acquired Brain Injury?
A study testing single leg stance treatment and Usual physiotherapy in people with Acquired Brain Injury, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The purpose of the study is to see if a person can stand better on their weaker leg does this improve their walking ability following treatment specifically aimed at standing on leg. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- single leg stance treatment and Usual physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Dec 2019to 8 Jul 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an ABI as diagnosed by a doctor following a brain scan
- Adults aged eighteen years or over
- Patients can be male or female
- Mobile >10m with or without assistance/walking aid
- Willing and able to provide written informed consent and scores >5 on orientation on FIM+FAM (FIM+FAM is an outcome measure used in all neuro-rehabilitation units in England, consequently, these data are already captured by the unit)
- Medically stable - able to fully take part in regular therapy - as determined by the unit's medical team
Who cannot join
- Diagnosed with a progressive neurological condition by a doctor
- Below eighteen years of age
- Mobile <10m or not mobile
- Unable or unwilling to give informed consent or scores <5 on orientation on FIM+FAM Medically unwell
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Working on Single Leg Stance (SLS) Alongside Usual Physiotherapy Treatment Lead to a More Efficient Gait Pattern as Measured by the 10m Walk Test (10MWT) Compared to Those Receiving Usual Physiotherapy Only in Adults With Acquired Brain Injury? An Exploratory Study.
The purpose of the study is to see if a person can stand better on their weaker leg does this improve their walking ability following treatment specifically aimed at standing on leg. This will be compared to people who receive normal physiotherapy treatment not treatment specifically focusing on their ability to stand on their weaker leg. The study is being carried out as part of the researcher's Masters Degree. Participants will be allocated to either the control group (normal physiotherapy treatment) or the experimental group (normal physiotherapy plus physiotherapy working specifically on standing on the weaker leg). There is currently some evidence to show that working specifically on standing on one leg can improve a person's walking but this evidence is limited. Consequently, further research is warranted to identify any links between this treatment approach and walking ability.
Read the detailed description
Acquired brain injury (ABI) incidence is 369 per 100,000 people internationally and 260 per 100,000 in the UK resulting in more than 900,000 people living with the long term effects of a cerebrovascular accident (CVA) and over 380,000 with impairments following traumatic brain injury. The ABI population often experience long term health problems affecting physical functioning, cognition, communication, emotion and behaviour with a loss of physical functioning and an inability to walk highlighted as the most negative aspect by patients. Several studies have identified people with neurological impairment who regain walking often mobilise at slower speeds with a mean gait velocity of 73.07cm/s for CVA survivors (60cm/s slower than healthy adults).
The gait cycle is described as having two major components, stance and swing phase. Stance has been determined as a pre-requisite for gait and a literature review found reduced stance ability correlates with gait abnormalities in CVA survivors. Consequently, given that a stronger and longer stance phase leads to a better swing phase and stance accounts for 60% of the gait cycle, stance can be considered the most important part of the gait cycle.
A person's ability to achieve SLS can be measured using the SLS test which assesses the time a person can stand on one leg. SLS test has excellent intra-rater reliability with an intraclass correlation coefficient (ICC) of 0.83 and excellent validity with a correlation of <10 seconds being a high predictor of mobility impairments for people with ABI. There is currently no definitive minimal clinical important difference (MCID) for the SLS test - current literature varies from 5.5 - 16.0 seconds - but as this study will assess the quality of each person's SLS test as opposed to the time the results will still be clinically relevant.
Goal Attainment Scale (GAS) based on the single leg stance (SLS) test will be used to assess quality as it is responsive to change, person-specific and quantitative, able to assess treatment interventions at the impairment and functional level, and is suitable for assessing and evaluating patient outcomes in the ABI population and is frequently used within neuro-rehabilitation. GAS has excellent intra-rater reliability (ICC 0.88-0.93) and inter-rater reliability (ICC 0.95) with good concurrent and predictive and moderate to good content and construct validity (r=0.28-0.63) across the ABI population.
The ten metre walk test (10MWT) will be used to assess gait efficiency. The 10MWT requires a patient to walk ten metres at a comfortable speed and the time taken to cover that distance is measured. Studies have found a relationship between reduced SLS and reduced speed in the 10MWT with improvements in gait speed demonstrated following intervention based on SLS. It is also hypothesised that increased gait speed results in a more efficient and fluent gait pattern. Consequently, 10MWT will be used in this study to demonstrate gait velocity and efficiency improvements. 10MWT is also one of the most common, reliable, efficient and robust outcomes measures within neuro-rehabilitation. 10MWT demonstrates excellent test-retest reliability (ICC 0.95-0.99) and excellent intra-rater (ICC 0.87-0.98) and inter-rater reliability (ICC 0.99). 10MWT also has excellent criterion validity of r=0.76-0.78 and excellent construct validity (r=0.62-0.92) for various outcome measures within the ABI population with an MCID of 0.14-0.16m/s.
Consequently, ABI results in a reduced ability to achieve SLS which has a negative influence on gait speed and efficiency. Studies of predominantly small samples have demonstrated working on SLS can improve gait speed and efficiency in CVA survivors and to a lesser extent the traumatic brain injury (TBI) population meaning there is a gap in the research surrounding the ABI population as a whole including TBI. Therefore, this study will aim to answer the question 'does improved ability to achieve SLS lead to a more efficient gait pattern in adults with acquired brain injury?' The null hypothesis is 'improved ability to achieve SLS does not lead to a more efficient gait pattern in patients with ABI'. The experimental hypothesis is 'improved ability to achieve SLS does lead to a more efficient gait pattern in patients with ABI'. This is a two-tailed hypothesis due to limited evidence regarding the testing direction.
This will be an exploratory pre-test - post-test experimental design as it allows testing of two variables (dependent and independent) to identify the cause and effect of specific events. This research design also helps determine if the subjects' performance is better, worse or unchanged and the inclusion of a control group will provide more convincing evidence of success or failure of treatment. The control group will receive an individualised physiotherapy treatment approach, but it will not work specifically on SLS i.e. they will receive their normal physiotherapy treatment.
- Conditions
- Acquired Brain Injury
- Being tested
- single leg stance treatment, Usual physiotherapy
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single leg stance treatmentOther
SLS treatment following the neurodevelopmental treatment (NDT). SLS is the ability of one limb to support the body's weight in a standing position. In gait it is the foot being in contact with the ground whilst the body passes over it and this stance phase of gait accounts for 60% of the gait cycle. The treatment approach of NDT has been chosen as this is the most common physiotherapy treatment option in the UK and is the most common option in the studies above. NDT is a problem-solving approach to the assessment and treatment of individuals with disturbances of function, movement and postural control due to a lesion of the central nervous system and provides an outline of the treatment required to achieve SLS which will form the basis of the intervention of this study.
Usual physiotherapyOther
Individualised physiotherapy treatment approach, as per standard protocol, but it will not work specifically on SLS. Will be based on the neuro-developmental technique.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | The control group will be the group where the participants receive only their normal physiotherapy treatment. Receives: Other: Usual physiotherapy |
| Experimental Group | Experimental | The experimental group will be the group where participants receive physiotherapy aimed at improving their ability to stand on their weaker leg alongside their normal physiotherapy treatment. Receives: Other: single leg stance treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with improved gait speed as measured by an increase in metres per second in the 10m walk test (10MWT)
The 10m walk test (10MWT) is a measure of gait speed. Time to walk 10m is converted to metres/second. This will be completed pre and post intervention and the difference compared. An increase in speed (metres per second) demonstrates a positive outcome. A change of greater than 0.14m/s indicates a clinical important difference.
Measured: 6 weeks
Secondary outcomes (1)
Number of participants who improve their ability to achieve single leg stance (SLS) with a change in Goal Attainment Scale (GAS) T-score of greater than 10
Goal Attainment Scale (GAS) enables patient outcomes to be documented on a scale of -2 to +2 with -1 accepted as the baseline and 0 as the anticipated outcome. This is completed pre and post intervention and converted to a T-score with a mean of 50. An increase in the T-score indicates a positive outcome. A difference of 10 is seen as a clinically important difference.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start24 Dec 2019
- Primary completion8 Jul 2020
- Study completion8 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exploratory pre-test - post-test experimental design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Salford
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062149
- Sponsor's protocol ID
- B00678
- Status last verified
- Oct 2020
- First submitted
- 16 Aug 2019
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allen JL, Kautz SA, Neptune RR. Step length asymmetry is representative of compensatory mechanisms used in post-stroke hemiparetic walking. Gait Posture. 2011 Apr;33(4):538-43. doi: 10.1016/j.gaitpost.2011.01.004. Epub 2011 Feb 11.
PubMed 21316240Baker JM. Gait Disorders. Am J Med. 2018 Jun;131(6):602-607. doi: 10.1016/j.amjmed.2017.11.051. Epub 2017 Dec 27.
PubMed 29288631Brandstater ME, de Bruin H, Gowland C, Clark BM. Hemiplegic gait: analysis of temporal variables. Arch Phys Med Rehabil. 1983 Dec;64(12):583-7.
PubMed 6661021Bonora G, Mancini M, Carpinella I, Chiari L, Ferrarin M, Nutt JG, Horak FB. Investigation of Anticipatory Postural Adjustments during One-Leg Stance Using Inertial Sensors: Evidence from Subjects with Parkinsonism. Front Neurol. 2017 Jul 25;8:361. doi: 10.3389/fneur.2017.00361. eCollection 2017.
PubMed 28790972Bovend'Eerdt TJ, Dawes H, Izadi H, Wade DT. Agreement between two different scoring procedures for goal attainment scaling is low. J Rehabil Med. 2011 Jan;43(1):46-9. doi: 10.2340/16501977-0624.
PubMed 21042701Brock K, Haase G, Rothacher G, Cotton S. Does physiotherapy based on the Bobath concept, in conjunction with a task practice, achieve greater improvement in walking ability in people with stroke compared to physiotherapy focused on structured task practice alone?: a pilot randomized controlled trial. Clin Rehabil. 2011 Oct;25(10):903-12. doi: 10.1177/0269215511406557. Epub 2011 Jul 25.
PubMed 21788266Burnfield JM, Buster TW, Goldman AJ, Corbridge LM, Harper-Hanigan K. Partial body weight support treadmill training speed influences paretic and non-paretic leg muscle activation, stride characteristics, and ratings of perceived exertion during acute stroke rehabilitation. Hum Mov Sci. 2016 Jun;47:16-28. doi: 10.1016/j.humov.2016.01.012. Epub 2016 Feb 1.
PubMed 26845732Carvalho C, Sunnerhagen KS, Willen C. Walking performance and muscle strength in the later stage poststroke: a nonlinear relationship. Arch Phys Med Rehabil. 2013 May;94(5):845-50. doi: 10.1016/j.apmr.2012.11.034. Epub 2012 Dec 3.
PubMed 23219614Chomiak T, Pereira FV, Hu B. The single-leg-stance test in Parkinson's disease. J Clin Med Res. 2015 Mar;7(3):182-5. doi: 10.14740/jocmr1878w. Epub 2014 Dec 29.
PubMed 25584104Dorsch S, Ada L, Canning CG, Al-Zharani M, Dean C. The strength of the ankle dorsiflexors has a significant contribution to walking speed in people who can walk independently after stroke: an observational study. Arch Phys Med Rehabil. 2012 Jun;93(6):1072-6. doi: 10.1016/j.apmr.2012.01.005. Epub 2012 Mar 29.
PubMed 22464738Drummond, A. (1998). Research methods for therapists. Cheltenham: Cheltenham : Stanley Thornes.
Evans JJ. Goal setting during rehabilitation early and late after acquired brain injury. Curr Opin Neurol. 2012 Dec;25(6):651-5. doi: 10.1097/WCO.0b013e3283598f75.
PubMed 23007008Gatrell, S. (2006). The use of the Bobath Concept to facilitate single leg stance and the influence of this on gait in patients following stroke. Synapse, Spring, 11-15.
Graham JE, Ostir GV, Kuo YF, Fisher SR, Ottenbacher KJ. Relationship between test methodology and mean velocity in timed walk tests: a review. Arch Phys Med Rehabil. 2008 May;89(5):865-72. doi: 10.1016/j.apmr.2007.11.029.
PubMed 18452733Hurn J, Kneebone I, Cropley M. Goal setting as an outcome measure: A systematic review. Clin Rehabil. 2006 Sep;20(9):756-72. doi: 10.1177/0269215506070793.
PubMed 17005500
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Working on Single Leg Stance (SLS) Alongside Usual Physiotherapy Treatment Lead to a More Efficient Gait Pattern as Measured by the 10m Walk Test (10MWT) Compared to Those Receiving Usual Physiotherapy Only in Adults With Acquired Brain Injury? An Exploratory Study.
- ClinicalTrials.gov ID
- NCT04062149
- Acronym / sponsor ID
- B00678
- Conditions
- Acquired Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- University of Salford
- Study start
- 24 Dec 2019 (actual)
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 20 Aug 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.
The purpose of the study is to see if a person can stand better on their weaker leg does this improve their walking ability following treatment specifically aimed at standing on leg. This will be compared to people who receive normal physiotherapy treatment not treatment specifically focusing on their ability to stand on their weaker leg. The study is being carried out as part of the researcher's Masters Degree. Participants will be allocated to either the control group (normal physiotherapy treatment) or the experimental group (normal physiotherapy plus physiotherapy working specifically on standing on the weaker leg). There is currently some evidence to show that working specifically on standing on one leg can improve a person's walking but this evidence is limited. Consequently, further research is warranted to identify any links between this treatment approach and walking ability.
Detailed description
Acquired brain injury (ABI) incidence is 369 per 100,000 people internationally and 260 per 100,000 in the UK resulting in more than 900,000 people living with the long term effects of a cerebrovascular accident (CVA) and over 380,000 with impairments following traumatic brain injury. The ABI population often experience long term health problems affecting physical functioning, cognition, communication, emotion and behaviour with a loss of physical functioning and an inability to walk highlighted as the most negative aspect by patients. Several studies have identified people with neurological impairment who regain walking often mobilise at slower speeds with a mean gait velocity of 73.07cm/s for CVA survivors (60cm/s slower than healthy adults).
The gait cycle is described as having two major components, stance and swing phase. Stance has been determined as a pre-requisite for gait and a literature review found reduced stance ability correlates with gait abnormalities in CVA survivors. Consequently, given that a stronger and longer stance phase leads to a better swing phase and stance accounts for 60% of the gait cycle, stance can be considered the most important part of the gait cycle.
A person's ability to achieve SLS can be measured using the SLS test which assesses the time a person can stand on one leg. SLS test has excellent intra-rater reliability with an intraclass correlation coefficient (ICC) of 0.83 and excellent validity with a correlation of <10 seconds being a high predictor of mobility impairments for people with ABI. There is currently no definitive minimal clinical important difference (MCID) for the SLS test - current literature varies from 5.5 - 16.0 seconds - but as this study will assess the quality of each person's SLS test as opposed to the time the results will still be clinically relevant.
Goal Attainment Scale (GAS) based on the single leg stance (SLS) test will be used to assess quality as it is responsive to change, person-specific and quantitative, able to assess treatment interventions at the impairment and functional level, and is suitable for assessing and evaluating patient outcomes in the ABI population and is frequently used within neuro-rehabilitation. GAS has excellent intra-rater reliability (ICC 0.88-0.93) and inter-rater reliability (ICC 0.95) with good concurrent and predictive and moderate to good content and construct validity (r=0.28-0.63) across the ABI population.
The ten metre walk test (10MWT) will be used to assess gait efficiency. The 10MWT requires a patient to walk ten metres at a comfortable speed and the time taken to cover that distance is measured. Studies have found a relationship between reduced SLS and reduced speed in the 10MWT with improvements in gait speed demonstrated following intervention based on SLS. It is also hypothesised that increased gait speed results in a more efficient and fluent gait pattern. Consequently, 10MWT will be used in this study to demonstrate gait velocity and efficiency improvements. 10MWT is also one of the most common, reliable, efficient and robust outcomes measures within neuro-rehabilitation. 10MWT demonstrates excellent test-retest reliability (ICC 0.95-0.99) and excellent intra-rater (ICC 0.87-0.98) and inter-rater reliability (ICC 0.99). 10MWT also has excellent criterion validity of r=0.76-0.78 and excellent construct validity (r=0.62-0.92) for various outcome measures within the ABI population with an MCID of 0.14-0.16m/s.
Consequently, ABI results in a reduced ability to achieve SLS which has a negative influence on gait speed and efficiency. Studies of predominantly small samples have demonstrated working on SLS can improve gait speed and efficiency in CVA survivors and to a lesser extent the traumatic brain injury (TBI) population meaning there is a gap in the research surrounding the ABI population as a whole including TBI. Therefore, this study will aim to answer the question 'does improved ability to achieve SLS lead to a more efficient gait pattern in adults with acquired brain injury?' The null hypothesis is 'improved ability to achieve SLS does not lead to a more efficient gait pattern in patients with ABI'. The experimental hypothesis is 'improved ability to achieve SLS does lead to a more efficient gait pattern in patients with ABI'. This is a two-tailed hypothesis due to limited evidence regarding the testing direction.
This will be an exploratory pre-test - post-test experimental design as it allows testing of two variables (dependent and independent) to identify the cause and effect of specific events. This research design also helps determine if the subjects' performance is better, worse or unchanged and the inclusion of a control group will provide more convincing evidence of success or failure of treatment. The control group will receive an individualised physiotherapy treatment approach, but it will not work specifically on SLS i.e. they will receive their normal physiotherapy treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Exploratory pre-test - post-test experimental design
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Usual physiotherapyThe control group will be the group where the participants receive only their normal physiotherapy treatment. |
| Experimental Group | Experimental | Other: single leg stance treatmentThe experimental group will be the group where participants receive physiotherapy aimed at improving their ability to stand on their weaker leg alongside their normal physiotherapy treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with an ABI as diagnosed by a doctor following a brain scan
- Adults aged eighteen years or over
- Patients can be male or female
- Mobile >10m with or without assistance/walking aid
- Willing and able to provide written informed consent and scores >5 on orientation on FIM+FAM (FIM+FAM is an outcome measure used in all neuro-rehabilitation units in England, consequently, these data are already captured by the unit)
Key exclusion criteria (4 listed)
- Diagnosed with a progressive neurological condition by a doctor
- Below eighteen years of age
- Mobile <10m or not mobile
- Unable or unwilling to give informed consent or scores <5 on orientation on FIM+FAM Medically unwell
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 |
|---|---|---|
| single leg stance treatmentSLS treatment following the neurodevelopmental treatment (NDT). SLS is the ability of one limb to support the body's weight in a standing position. In gait it is the foot being in contact with the ground whilst the body passes over it and this stance phase of gait accounts for 60% of the gait cycle. The treatment approach of NDT has been chosen as this is the most common physiotherapy treatment option in the UK and is the most common option in the studies above. NDT is a problem-solving approach to the assessment and treatment of individuals with disturbances of function, movement and postural control due to a lesion of the central nervous system and provides an outline of the treatment required to achieve SLS which will form the basis of the intervention of this study. | Other | Experimental Group |
| Usual physiotherapyIndividualised physiotherapy treatment approach, as per standard protocol, but it will not work specifically on SLS. Will be based on the neuro-developmental technique. | Other | Control Group |
Primary outcome
Number of participants with improved gait speed as measured by an increase in metres per second in the 10m walk test (10MWT)
Time frame: 6 weeks
The 10m walk test (10MWT) is a measure of gait speed. Time to walk 10m is converted to metres/second. This will be completed pre and post intervention and the difference compared. An increase in speed (metres per second) demonstrates a positive outcome. A change of greater than 0.14m/s indicates a clinical important difference.
1 secondary outcome
Number of participants who improve their ability to achieve single leg stance (SLS) with a change in Goal Attainment Scale (GAS) T-score of greater than 10
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 21316240Allen JL, Kautz SA, Neptune RR. Step length asymmetry is representative of compensatory mechanisms used in post-stroke hemiparetic walking. Gait Posture. 2011 Apr;33(4):538-43. doi: 10.1016/j.gaitpost.2011.01.004. Epub 2011 Feb 11.
- Background: PubMed 29288631Baker JM. Gait Disorders. Am J Med. 2018 Jun;131(6):602-607. doi: 10.1016/j.amjmed.2017.11.051. Epub 2017 Dec 27.
- Background: PubMed 6661021Brandstater ME, de Bruin H, Gowland C, Clark BM. Hemiplegic gait: analysis of temporal variables. Arch Phys Med Rehabil. 1983 Dec;64(12):583-7.
- Background: PubMed 28790972Bonora G, Mancini M, Carpinella I, Chiari L, Ferrarin M, Nutt JG, Horak FB. Investigation of Anticipatory Postural Adjustments during One-Leg Stance Using Inertial Sensors: Evidence from Subjects with Parkinsonism. Front Neurol. 2017 Jul 25;8:361. doi: 10.3389/fneur.2017.00361. eCollection 2017.
- Background: PubMed 21042701Bovend'Eerdt TJ, Dawes H, Izadi H, Wade DT. Agreement between two different scoring procedures for goal attainment scaling is low. J Rehabil Med. 2011 Jan;43(1):46-9. doi: 10.2340/16501977-0624.
- Background: PubMed 21788266Brock K, Haase G, Rothacher G, Cotton S. Does physiotherapy based on the Bobath concept, in conjunction with a task practice, achieve greater improvement in walking ability in people with stroke compared to physiotherapy focused on structured task practice alone?: a pilot randomized controlled trial. Clin Rehabil. 2011 Oct;25(10):903-12. doi: 10.1177/0269215511406557. Epub 2011 Jul 25.
- Background: PubMed 26845732Burnfield JM, Buster TW, Goldman AJ, Corbridge LM, Harper-Hanigan K. Partial body weight support treadmill training speed influences paretic and non-paretic leg muscle activation, stride characteristics, and ratings of perceived exertion during acute stroke rehabilitation. Hum Mov Sci. 2016 Jun;47:16-28. doi: 10.1016/j.humov.2016.01.012. Epub 2016 Feb 1.
- Background: PubMed 23219614Carvalho C, Sunnerhagen KS, Willen C. Walking performance and muscle strength in the later stage poststroke: a nonlinear relationship. Arch Phys Med Rehabil. 2013 May;94(5):845-50. doi: 10.1016/j.apmr.2012.11.034. Epub 2012 Dec 3.
- Background: PubMed 25584104Chomiak T, Pereira FV, Hu B. The single-leg-stance test in Parkinson's disease. J Clin Med Res. 2015 Mar;7(3):182-5. doi: 10.14740/jocmr1878w. Epub 2014 Dec 29.
- Background: PubMed 22464738Dorsch S, Ada L, Canning CG, Al-Zharani M, Dean C. The strength of the ankle dorsiflexors has a significant contribution to walking speed in people who can walk independently after stroke: an observational study. Arch Phys Med Rehabil. 2012 Jun;93(6):1072-6. doi: 10.1016/j.apmr.2012.01.005. Epub 2012 Mar 29.
- BackgroundDrummond, A. (1998). Research methods for therapists. Cheltenham: Cheltenham : Stanley Thornes.
- Background: PubMed 23007008Evans JJ. Goal setting during rehabilitation early and late after acquired brain injury. Curr Opin Neurol. 2012 Dec;25(6):651-5. doi: 10.1097/WCO.0b013e3283598f75.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single leg stance treatment and Usual physiotherapy in people with Acquired Brain Injury, run by Manchester University NHS Foundation Trust 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 14 Oct 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with improved gait speed as measured by an increase in metres per second in the 10m walk test (10MWT) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04062149, which also lists 52 linked publications.
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 Oct 2020.