Hereditary Spastic Paraplegia Clinical Trial
— Move-HSPOfficial title:
Improving Gait Adaptability in Hereditary Spastic Paraplegia During Task-specific Training on the C-Mill: Towards Evidence-Based and Individually Tailored Rehabilitation
NCT number | NCT04180098 |
Other study ID # | 108836 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 1, 2019 |
Est. completion date | April 15, 2022 |
Verified date | March 2021 |
Source | Radboud University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | April 15, 2022 |
Est. primary completion date | April 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion criteria: - 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). Exclusion criteria: - Other neurological or serious orthopaedic or psychiatric co-morbidity - Previous HSP-related surgical interventions of the lower extremities. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboud universitair medisch centrum | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center | Jacques and Gloria Gossweiler Foundation |
Netherlands,
Fonteyn 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. — View Citation
Heeren 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. — View Citation
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. Review. — View Citation
Salinas 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | Pre C-mill intervention (experimental group week 0, control group week 6), post C-Mill intervention (experimental group week 6, control group week 12) and after the follow-up period of fifteen weeks (experimental group week 21, control group week 27) | |
Other | 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. | Pre C-mill intervention (experimental group week 0, control group week 6), post C-Mill intervention (experimental group week 6, control group week 12) and after the follow-up period of fifteen weeks (experimental group week 21, control group week 27) | |
Other | 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. | Pre C-mill intervention (experimental group week 0, control group week 6), post C-Mill intervention (experimental group week 6, control group week 12) and after the follow-up period of fifteen weeks (experimental group week 21, control group week 27) | |
Other | 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). | Pre C-mill intervention (experimental group week 0, control group week 6) and post C-Mill intervention (experimental group week 6, control group week 12) | |
Other | 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. | Pre C-mill intervention (experimental group week 0, control group week 6), post C-Mill intervention (experimental group week 6, control group week 12) and after the follow-up period of fifteen weeks (experimental group week 21, control group week 27) | |
Other | 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. | Pre C-mill intervention (experimental group week 0, control group week 6), post C-Mill intervention (experimental group week 6, control group week 12) and after the follow-up period of fifteen weeks (experimental group week 21, control group week 27) | |
Other | 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. | Pre C-mill intervention (experimental group week 0, control group week 6), post C-Mill intervention (experimental group week 6, control group week 12) and after the follow-up period of fifteen weeks (experimental group week 21, control group week 27) | |
Primary | 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 | Pre-intervention (week 0) till post-intervention (week 6) | |
Secondary | 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. | Pre-intervention (week 0) till post-intervention (week 6) | |
Secondary | 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. | Pre-intervention (week 0) till post-intervention (week 6) | |
Secondary | 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). | Pre-intervention (week 0) till post-intervention (week 6) | |
Secondary | 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. | Pre-intervention (week 0) till post-intervention (week 6) | |
Secondary | 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. | Pre-intervention (week 0) and after the follow-up period of fifteen weeks (experimental group week 21, control group week 27) | |
Secondary | 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. | Pre-intervention (week 0) till post-intervention (week 6) | |
Secondary | 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. | Pre-intervention (week 0) till post-intervention (week 6) |
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