Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Gait Adaptability in Hereditary Spastic Paraplegia (Move-HSP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04180098
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : April 6, 2020
Sponsor:
Collaborator:
Jacques and Gloria Gossweiler Foundation
Information provided by (Responsible Party):
Radboud University

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Hereditary Spastic Paraplegia Strumpell Disease Behavioral: C-mill intervention Other: No intervention Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Basic Science
Official Title: Improving Gait Adaptability in Hereditary Spastic Paraplegia During Task-specific Training on the C-Mill: Towards Evidence-Based and Individually Tailored Rehabilitation
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : September 30, 2021


Arm Intervention/treatment
Experimental: Context specific C-mill training
Five week C-mill training on gait adaptability.
Behavioral: C-mill intervention
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.

Usual care
Usual care for participants with HSP. May vary per individual.
Behavioral: C-mill intervention
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.

Other: No intervention
Participants in the control group are placed on a waiting list.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 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.

  2. The mean change of the mini balance evaluation system [ Time Frame: Pre-intervention (week 0) till post-intervention (week 6) ]
    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.

  3. 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) ]
    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).

  4. The mean changes in scores of the activities specific balance confidence scale [ Time Frame: Pre-intervention (week 0) till post-intervention (week 6) ]
    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.

  5. 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) ]
    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.

  6. The mean change in the time score on the walking adaptability ladder test [ Time Frame: Pre-intervention (week 0) till post-intervention (week 6) ]
    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.

  7. Mean changes in spatio-temporal gait parameters [ Time Frame: Pre-intervention (week 0) till post-intervention (week 6) ]
    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.


Other Outcome Measures:
  1. The mean changes in time scores of the obstacle subtask of the emory functional ambulation profile [ Time Frame: 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) ]
    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

  2. The mean change in the time score on the ten meter walk test [ Time Frame: 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) ]
    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.

  3. The mean change of the mini balance evaluation system [ Time Frame: 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) ]
    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.

  4. Mean changes of activity levels measured as time spent active of passive during 24 hours [ Time Frame: 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) ]
    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).

  5. The mean changes in scores of the activities specific balance confidence scale [ Time Frame: 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) ]
    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.

  6. The mean change in the time score on the walking adaptability ladder test [ Time Frame: 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) ]
    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.

  7. Mean changes in spatio-temporal gait parameters [ Time Frame: 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) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04180098


Contacts
Layout table for location contacts
Contact: Lotte L van de Venis, MSc 0031243668426 lotte.vandevenis@radboudumc.nl

Locations
Layout table for location information
Netherlands
Radboud universitair medisch centrum Recruiting
Nijmegen, Netherlands, 6500 HB
Contact: Lotte van de Venis, MSc    (024) 366 84 26    Lotte.vandevenis@radboudumc.nl   
Sponsors and Collaborators
Radboud University
Jacques and Gloria Gossweiler Foundation
Investigators
Layout table for investigator information
Principal Investigator: A.C.H. Geurts, Prof. Dr. Radboud University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT04180098    
Other Study ID Numbers: 108836
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University:
hereditary spastic paraplegia
C-mill
gait adaptability
rehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Spasticity
Paraplegia
Spastic Paraplegia, Hereditary
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Paralysis
Hereditary Sensory and Motor Neuropathy
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Congenital Abnormalities
Genetic Diseases, Inborn