Hereditary Spastic ParaplegiaMove-HSPNCT04180098
Improving Gait Adaptability in Hereditary Spastic Paraplegia
A study testing C-mill intervention in people with Hereditary Spastic Paraplegia and Strumpell Disease, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
This study evaluates the effects of ten hours C-mill training on gait adaptability in participants with hereditary spastic paraplegia (HSP). Half of the participants start with five weeks of C-mill training (ten 1-hour sessions). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hereditary Spastic Paraplegia, Strumpell Disease
- What is being tested?
- C-mill intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2019to 15 Apr 2022
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of pure-HSP based on molecular diagnosis or based on inheritance pattern
- Aged between 18-70 years old
- Being able to walk barefoot on a level ground for 50 meters without a walking aid (use of orthopaedic devices or made-to-measure footwear is allowed).
Who cannot join
- Other neurological or serious orthopaedic or psychiatric co-morbidity
- Previous HSP-related surgical interventions of the lower extremities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Gait Adaptability in Hereditary Spastic Paraplegia During Task-specific Training on the C-Mill: Towards Evidence-Based and Individually Tailored Rehabilitation
This study evaluates the effects of ten hours C-mill training on gait adaptability in participants with hereditary spastic paraplegia (HSP). Half of the participants start with five weeks of C-mill training (ten 1-hour sessions). The other participants are placed on a waiting list, which is followed by the same five weeks of C-mill training (ten 1-hour sessions). It is hypothesized that ten hours of context specific C-mill training is effective in improving gait adaptability in participants with pure HSP.
Read the detailed description
Hereditary spastic paraplegia (HSP) is a relatively common, slowly progressive movement disorder that seriously impacts on gait capacity. Patients with HSP experience incremental muscle stiffness, muscle weakness and balance problems and, as a consequence, increasing difficulties to adjust their gait pattern to changing environmental demands. This is a major problem as such 'gait adaptability' is critical for independent and safe mobility in daily life. Impaired gait adaptability will also result in falls and fall-related injuries and reduce quality of life. Therefore, there is an urgent need for evidence-based rehabilitation interventions to improve gait adaptability in patients with HSP. Participants train gait adaptability via obstacle negotiation, precision stepping and unexpected accelerations and decelerations. The strategies are trained in a safe environment on the C-Mill, a treadmill providing augmented reality via visual and acoustic cues.
Objectives
This study aims to promote an essential step towards evidence-based and individually tailored gait rehabilitation in participants with hereditary spastic paraparesis. The objectives are twofold:
- To study the effect of ten 1-hour sessions C-Mill training on gait adaptability in participants with pure-HSP.
- To study the effect of ten 1-hour sessions C-Mill training on spatiotemporal and functional capacity parameters and to identify key-determinants of C-Mill training efficacy in participants with pure-HSP.
It is hypothesized that ten hours of context specific C-mill training is effective in improving gait adaptability in participants with pure HSP, as measured with the obstacle subtask of the emory functional ambulation profile (E-FAP).
Sample size calculation is based on previous studies concerning the effects of gait adaptability interventions on the obstacle subtask of the E-FAP. A total of 32 participants is sufficient to demonstrate an expected improvement on the obstacle subtask score of the E-FAP. To allow a 10% attrition rate, 36 participants will be included.
Participants will be recruited from the Radboud Expert Centre of Genetic Movement Disorders (part of the ERN-RND) which has specific HSP expertise. The treating physician of the patient will ask whether the investigator may contact the patient. Furthermore, mailings through the HSP patient group, that is part of the patient organization "Spierziekten Nederland", will be sent to their members with HSP. If patients are interested in participating, they can contact the investigator and will be informed via an information letter (to which the informed consent form is attached). Participants will then have two weeks to consider their decision whether to participate. After the two week period, the investigator will contact them about their decision.
Data will be coded numerically (e.g. HSP01, HSP02) and an identification code list will be used to link the data to the participant. The key to the code will be safeguarded by the investigators. The project leader and all other investigators will have access to the source data. Data will be kept for fifteen years. The handling of data will comply with the Dutch Personal Data Protection Act and participants' privacy will be protected. The monitoring will be performed according to NFU guidelines for negligible risk intensity.
Descriptive data analysis will be used to outline characteristics of both intervention groups. The effect of gait adaptability training on primary and secondary outcomes will be tested using ANCOVA. Post-intervention measurements will be used as dependent variables and Group (C-Mill versus waiting list) and pre-intervention measurements as independent between-subjects factors. Time will be tested as a within-subjects factor. The retention of gait adaptability training will be tested by merging both groups and using a repeated measures ANOVA with Time as a within-subjects factor (C-Mill group: measurements 1, 2 and 3; waiting list: measurements 2, 3 and 4). Post-hoc tests will be performed in the case of significant main or interaction effects, using paired t-tests. Fall rates will be processed descriptively. Depending on the distribution of the data, the rate of near falls may be analyzed using Wilcoxon signed rank test. In addition, to determine key determinants of C-Mill training efficacy, a stepwise linear regression analysis will be performed with training-induced change in gait adaptability (relative change of the obstacle subtask of the E-FAP) as the dependent variable. Univariate analyses will be performed to select the best factors from the available demographic and clinical characteristics.
Adverse events All adverse events reported spontaneously by the participants or observed by the investigator or his staff will be recorded. The sponsor will report the SAEs through the web portal ToetsingOnline to the accredited METC that approved the protocol, within seven days of first knowledge for SAEs that result in death or are life threatening followed by a period of maximum of 8 days to complete the initial preliminary report. All other SAEs will be reported within a period of maximum 15 days after the sponsor has first knowledge of the serious adverse events. The risk associated with participation will be negligible, according to the risk classification of the NFU. Burden associated with the measurements will be limited, as the number of measurements will be relatively low.
- Conditions
- Hereditary Spastic Paraplegia, Strumpell Disease
- Being tested
- C-mill intervention, No intervention
- Keywords
- hereditary spastic paraplegia, C-mill, gait adaptability, rehabilitation
- Medical subject headings
- Spastic Paraplegia, Hereditary, Spastic paraplegia 3, autosomal dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-mill interventionBehavioural
A five week personalised rehabilitation program. Participants train gait adaptability via obstacle negotiation, precision stepping and unexpected accelerations and decelerations. The strategies are trained in a safe environment on the C-mill, a treadmill providing augmented reality via visual and acoustic cues. The treatment is implemented in a five week period via 10 biweekly sessions. Each treatment session lasts 60 minutes. In total, participants will receive C-mill training for a total of ten hours. The training will be carried out by a skilled physiotherapist.
No interventionOther
Participants in the control group are placed on a waiting list.
| Study group | Role | What they receive |
|---|---|---|
| Context specific C-mill training | Experimental | Five week C-mill training on gait adaptability. Receives: Behavioral: C-mill intervention |
| Usual care | Other | Usual care for participants with HSP. May vary per individual. Receives: Behavioral: C-mill intervention; Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean changes in time scores of the obstacle subtask of the emory functional ambulation profile
Patients are asked to negotiate a ten meter obstacle course. The number of seconds it takes to complete the subtask is recorded, and multiplied by a factor corresponding to the level of assistive devices used. A lower time score indicates better obstacle negotiation
Measured: Pre-intervention (week 0) till post-intervention (week 6)
Secondary outcomes (7)
The mean change in the time score on the ten meter walk test
The ten meter walk test (10MWT) is a standardised and recommended measurement of walking velocity. Patients walk ten meters in a straight line: three times at a comfortable speed, and three times as fast as possible, whilst keeping safety in mind. The number of seconds it takes to walk ten meters is recorded.
Measured: Pre-intervention (week 0) till post-intervention (week 6)
The mean change of the mini balance evaluation system
The mini balance evaluation system (mini-BEST) is a 14-item, 3 points ordinal rating scale (0-2 points) to evaluate balance performance in 4 subcategories: anticipatory postural control, reactive postural control, sensory orientation and stability in gait. The attainable scores ranges from 0-28 points, in which a higher score indicates a higher balance performance.
Measured: Pre-intervention (week 0) till post-intervention (week 6)
Mean changes of activity levels measured as time spent active of passive during 24 hours
Physical activity levels of daily life will be registered via the Activ8 Monitor. The monitor consists of 3 axial accelerometers that is worn on the upper thigh. It registers body positions (lying/non-wear/sitting and standing) and activities (walking, running, cycling).
Measured: Pre-intervention (week 0) till post-intervention (week 6)
The mean changes in scores of the activities specific balance confidence scale
Balance confidence will be measured via the activities-specific balance confidence scale. This subjective questionnaire consisting of sixteen indoor and outdoor situations. Patients are asked to express their confidence to safely execute to proposed situations without falling. Scores range from 0-100 in which a higher scores indicates more confidence.
Measured: Pre-intervention (week 0) till post-intervention (week 6)
Mean changes in number of falls and near falls
Patients are asked to monitor their falls and near falls via a fall calendar. Patients are asked to fill in when the (near) fall occurred, a short description of the event and if the patients was injured.
Measured: Pre-intervention (week 0) and after the follow-up period of fifteen weeks (experimental group week 21, control group week 27)
The mean change in the time score on the walking adaptability ladder test
The walking adaptability ladder test (WALT) is a novel test for measuring stepping precision. A standardised ladder is placed on the floor. It consists of 19 rectangular planes which gradually decrease two centimetres in length (range: 64cm - 28cm). Patients starts in the biggest plane and walk as fast as possible to the other side, turn and return to the biggest plane whilst avoiding the ladder rungs. Scoring is via a time score: faster is indicative of better stepping precision. Patients perform the test four times: Twice with one feet per plane, and twice with both feet in one plane.
Measured: Pre-intervention (week 0) till post-intervention (week 6)
Mean changes in spatio-temporal gait parameters
Gait analysis is performed at the movement lab (Radboudumc, Nijmegen). Spatio-temporal parameters are assessed during a 3D full body gait analysis using the VICON analysis system ((©Vicon Motion Systems Ltd., London, UK). Eight infrared cameras measured the coordinates of the reflective markers. The following temporal gait parameters are assessed: stride length (m), step length (m), step width (m), duration of swing time (%), stance time (%), single support (%) and double support (%). Participants walk at their self-selected and maximum speed over a 10 meter walkway. A total of 3 trials per condition is recorded.
Measured: Pre-intervention (week 0) till post-intervention (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start1 Dec 2019
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hereditary Spastic ParaplegiaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants monitor their physical activity for 1 week, and falls for 15 weeks. After the screening, participants are randomized. Gait and balance capacity will be assessed in the movement lab of Radboudumc. Participants in the intervention group receives 5 weeks of C-mill training, which is immediately followed by an assessment in the movement lab, one-week of activity monitoring and fall monitoring during a 15 week follow-up period. After follow-up they will receive a final assessment in our movement lab. Participants in the control (waiting list) intervention, continue usual care for 5 weeks, followed by an assessment in the movement lab and one-week of activity monitoring. Subsequently, they receive 5 weeks of C-mill training, followed by an assessment in the movement lab, one-week of activity monitoring and fall monitoring in a follow-up period of 15 weeks. After follow-up, they receive a final assessment in the movement lab.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Jacques and Gloria Gossweiler Foundation
- Responsible party
- Sponsor
- Investigators
- A.C.H. Geurts, Prof. Dr., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180098
- Sponsor's protocol ID
- 108836
- Acronym
- Move-HSP
- Status last verified
- Mar 2021
- First submitted
- 20 Nov 2019
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nonnekes J, van Lith B, van de Warrenburg BP, Weerdesteyn V, Geurts ACH. Pathophysiology, diagnostic work-up and management of balance impairments and falls in patients with hereditary spastic paraplegia. J Rehabil Med. 2017 May 16;49(5):369-377. doi: 10.2340/16501977-2227.
PubMed 28471471Heeren A, van Ooijen M, Geurts AC, Day BL, Janssen TW, Beek PJ, Roerdink M, Weerdesteyn V. Step by step: a proof of concept study of C-Mill gait adaptability training in the chronic phase after stroke. J Rehabil Med. 2013 Jul;45(7):616-22. doi: 10.2340/16501977-1180.
PubMed 23811818Fonteyn EM, Heeren A, Engels JJ, Boer JJ, van de Warrenburg BP, Weerdesteyn V. Gait adaptability training improves obstacle avoidance and dynamic stability in patients with cerebellar degeneration. Gait Posture. 2014;40(1):247-51. doi: 10.1016/j.gaitpost.2014.04.190. Epub 2014 Apr 24.
PubMed 24786476Salinas S, Proukakis C, Crosby A, Warner TT. Hereditary spastic paraplegia: clinical features and pathogenetic mechanisms. Lancet Neurol. 2008 Dec;7(12):1127-38. doi: 10.1016/S1474-4422(08)70258-8.
PubMed 19007737van de Venis L, van de Warrenburg BPC, Weerdesteyn V, van Lith BJH, Geurts ACH, Nonnekes J. Improving gait adaptability in patients with hereditary spastic paraplegia (Move-HSP): study protocol for a randomized controlled trial. Trials. 2021 Jan 7;22(1):32. doi: 10.1186/s13063-020-04932-9.
PubMed 33413555
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Gait Adaptability in Hereditary Spastic Paraplegia During Task-specific Training on the C-Mill: Towards Evidence-Based and Individually Tailored Rehabilitation
- ClinicalTrials.gov ID
- NCT04180098
- Acronym / sponsor ID
- Move-HSP / 108836
- Conditions
- Hereditary Spastic Paraplegia, Strumpell Disease
- Keywords
- hereditary spastic paraplegia, C-mill, gait adaptability, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Jacques and Gloria Gossweiler Foundation
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 27 Nov 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 evaluates the effects of ten hours C-mill training on gait adaptability in participants with hereditary spastic paraplegia (HSP). Half of the participants start with five weeks of C-mill training (ten 1-hour sessions). The other participants are placed on a waiting list, which is followed by the same five weeks of C-mill training (ten 1-hour sessions). It is hypothesized that ten hours of context specific C-mill training is effective in improving gait adaptability in participants with pure HSP.
Detailed description
Hereditary spastic paraplegia (HSP) is a relatively common, slowly progressive movement disorder that seriously impacts on gait capacity. Patients with HSP experience incremental muscle stiffness, muscle weakness and balance problems and, as a consequence, increasing difficulties to adjust their gait pattern to changing environmental demands. This is a major problem as such 'gait adaptability' is critical for independent and safe mobility in daily life. Impaired gait adaptability will also result in falls and fall-related injuries and reduce quality of life. Therefore, there is an urgent need for evidence-based rehabilitation interventions to improve gait adaptability in patients with HSP. Participants train gait adaptability via obstacle negotiation, precision stepping and unexpected accelerations and decelerations. The strategies are trained in a safe environment on the C-Mill, a treadmill providing augmented reality via visual and acoustic cues.
Objectives
This study aims to promote an essential step towards evidence-based and individually tailored gait rehabilitation in participants with hereditary spastic paraparesis. The objectives are twofold:
- To study the effect of ten 1-hour sessions C-Mill training on gait adaptability in participants with pure-HSP.
- To study the effect of ten 1-hour sessions C-Mill training on spatiotemporal and functional capacity parameters and to identify key-determinants of C-Mill training efficacy in participants with pure-HSP.
It is hypothesized that ten hours of context specific C-mill training is effective in improving gait adaptability in participants with pure HSP, as measured with the obstacle subtask of the emory functional ambulation profile (E-FAP).
Sample size calculation is based on previous studies concerning the effects of gait adaptability interventions on the obstacle subtask of the E-FAP. A total of 32 participants is sufficient to demonstrate an expected improvement on the obstacle subtask score of the E-FAP. To allow a 10% attrition rate, 36 participants will be included.
Participants will be recruited from the Radboud Expert Centre of Genetic Movement Disorders (part of the ERN-RND) which has specific HSP expertise. The treating physician of the patient will ask whether the investigator may contact the patient. Furthermore, mailings through the HSP patient group, that is part of the patient organization "Spierziekten Nederland", will be sent to their members with HSP. If patients are interested in participating, they can contact the investigator and will be informed via an information letter (to which the informed consent form is attached). Participants will then have two weeks to consider their decision whether to participate. After the two week period, the investigator will contact them about their decision.
Data will be coded numerically (e.g. HSP01, HSP02) and an identification code list will be used to link the data to the participant. The key to the code will be safeguarded by the investigators. The project leader and all other investigators will have access to the source data. Data will be kept for fifteen years. The handling of data will comply with the Dutch Personal Data Protection Act and participants' privacy will be protected. The monitoring will be performed according to NFU guidelines for negligible risk intensity.
Descriptive data analysis will be used to outline characteristics of both intervention groups. The effect of gait adaptability training on primary and secondary outcomes will be tested using ANCOVA. Post-intervention measurements will be used as dependent variables and Group (C-Mill versus waiting list) and pre-intervention measurements as independent between-subjects factors. Time will be tested as a within-subjects factor. The retention of gait adaptability training will be tested by merging both groups and using a repeated measures ANOVA with Time as a within-subjects factor (C-Mill group: measurements 1, 2 and 3; waiting list: measurements 2, 3 and 4). Post-hoc tests will be performed in the case of significant main or interaction effects, using paired t-tests. Fall rates will be processed descriptively. Depending on the distribution of the data, the rate of near falls may be analyzed using Wilcoxon signed rank test. In addition, to determine key determinants of C-Mill training efficacy, a stepwise linear regression analysis will be performed with training-induced change in gait adaptability (relative change of the obstacle subtask of the E-FAP) as the dependent variable. Univariate analyses will be performed to select the best factors from the available demographic and clinical characteristics.
Adverse events All adverse events reported spontaneously by the participants or observed by the investigator or his staff will be recorded. The sponsor will report the SAEs through the web portal ToetsingOnline to the accredited METC that approved the protocol, within seven days of first knowledge for SAEs that result in death or are life threatening followed by a period of maximum of 8 days to complete the initial preliminary report. All other SAEs will be reported within a period of maximum 15 days after the sponsor has first knowledge of the serious adverse events. The risk associated with participation will be negligible, according to the risk classification of the NFU. Burden associated with the measurements will be limited, as the number of measurements will be relatively low.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants monitor their physical activity for 1 week, and falls for 15 weeks. After the screening, participants are randomized. Gait and balance capacity will be assessed in the movement lab of Radboudumc. Participants in the intervention group receives 5 weeks of C-mill training, which is immediately followed by an assessment in the movement lab, one-week of activity monitoring and fall monitoring during a 15 week follow-up period. After follow-up they will receive a final assessment in our movement lab. Participants in the control (waiting list) intervention, continue usual care for 5 weeks, followed by an assessment in the movement lab and one-week of activity monitoring. Subsequently, they receive 5 weeks of C-mill training, followed by an assessment in the movement lab, one-week of activity monitoring and fall monitoring in a follow-up period of 15 weeks. After follow-up, they receive a final assessment in the movement lab.
| Arm | Type | Receives |
|---|---|---|
| Context specific C-mill training | Experimental | Behavioral: C-mill interventionFive week C-mill training on gait adaptability. |
| Usual care | Other | Behavioral: C-mill intervention, Other: No interventionUsual care for participants with HSP. May vary per individual. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of pure-HSP based on molecular diagnosis or based on inheritance pattern
- Aged between 18-70 years old
- Being able to walk barefoot on a level ground for 50 meters without a walking aid (use of orthopaedic devices or made-to-measure footwear is allowed).
Key exclusion criteria (2 listed)
- Other neurological or serious orthopaedic or psychiatric co-morbidity
- Previous HSP-related surgical interventions of the lower extremities.
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 |
|---|---|---|
| C-mill interventionA five week personalised rehabilitation program. Participants train gait adaptability via obstacle negotiation, precision stepping and unexpected accelerations and decelerations. The strategies are trained in a safe environment on the C-mill, a treadmill providing augmented reality via visual and acoustic cues. The treatment is implemented in a five week period via 10 biweekly sessions. Each treatment session lasts 60 minutes. In total, participants will receive C-mill training for a total of ten hours. The training will be carried out by a skilled physiotherapist. | Behavioural | Context specific C-mill training, Usual care |
| No interventionParticipants in the control group are placed on a waiting list. | Other | Usual care |
Primary outcome
The mean changes in time scores of the obstacle subtask of the emory functional ambulation profile
Time frame: Pre-intervention (week 0) till post-intervention (week 6)
Patients are asked to negotiate a ten meter obstacle course. The number of seconds it takes to complete the subtask is recorded, and multiplied by a factor corresponding to the level of assistive devices used. A lower time score indicates better obstacle negotiation
7 secondary outcomes
The mean change in the time score on the ten meter walk test
Time frame: Pre-intervention (week 0) till post-intervention (week 6)
The mean change of the mini balance evaluation system
Time frame: Pre-intervention (week 0) till post-intervention (week 6)
Mean changes of activity levels measured as time spent active of passive during 24 hours
Time frame: Pre-intervention (week 0) till post-intervention (week 6)
The mean changes in scores of the activities specific balance confidence scale
Time frame: Pre-intervention (week 0) till post-intervention (week 6)
Mean changes in number of falls and near falls
Time frame: Pre-intervention (week 0) and after the follow-up period of fifteen weeks (experimental group week 21, control group week 27)
The mean change in the time score on the walking adaptability ladder test
Time frame: Pre-intervention (week 0) till post-intervention (week 6)
Mean changes in spatio-temporal gait parameters
Time frame: Pre-intervention (week 0) till post-intervention (week 6)
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 29 Apr 2022.
- Background: PubMed 28471471Nonnekes J, van Lith B, van de Warrenburg BP, Weerdesteyn V, Geurts ACH. Pathophysiology, diagnostic work-up and management of balance impairments and falls in patients with hereditary spastic paraplegia. J Rehabil Med. 2017 May 16;49(5):369-377. doi: 10.2340/16501977-2227.
- Background: PubMed 23811818Heeren A, van Ooijen M, Geurts AC, Day BL, Janssen TW, Beek PJ, Roerdink M, Weerdesteyn V. Step by step: a proof of concept study of C-Mill gait adaptability training in the chronic phase after stroke. J Rehabil Med. 2013 Jul;45(7):616-22. doi: 10.2340/16501977-1180.
- Background: PubMed 24786476Fonteyn EM, Heeren A, Engels JJ, Boer JJ, van de Warrenburg BP, Weerdesteyn V. Gait adaptability training improves obstacle avoidance and dynamic stability in patients with cerebellar degeneration. Gait Posture. 2014;40(1):247-51. doi: 10.1016/j.gaitpost.2014.04.190. Epub 2014 Apr 24.
- Background: PubMed 19007737Salinas S, Proukakis C, Crosby A, Warner TT. Hereditary spastic paraplegia: clinical features and pathogenetic mechanisms. Lancet Neurol. 2008 Dec;7(12):1127-38. doi: 10.1016/S1474-4422(08)70258-8.
- Derived from this study: PubMed 33413555van de Venis L, van de Warrenburg BPC, Weerdesteyn V, van Lith BJH, Geurts ACH, Nonnekes J. Improving gait adaptability in patients with hereditary spastic paraplegia (Move-HSP): study protocol for a randomized controlled trial. Trials. 2021 Jan 7;22(1):32. doi: 10.1186/s13063-020-04932-9.
- 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.
A.C.H. Geurts, Prof. Dr. principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-mill intervention in people with Hereditary Spastic Paraplegia and Strumpell Disease, run by Radboud University Medical Center at 1 site in Netherlands.
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 3 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: finished, as of the sponsor's last update on 29 Apr 2022. 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 Netherlands. 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?
The mean changes in time scores of the obstacle subtask of the emory functional ambulation profile (time frame: Pre-intervention (week 0) till post-intervention (week 6)). 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 NCT04180098, which also lists 5 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 29 Apr 2022.