Improving Gait Adaptability in Hereditary Spastic Paraplegia

NCT04180098 | Completed DMC

• 1 other identifier: 108836
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Hereditary Spastic Paraplegia; Strumpell Disease

Keywords

hereditary spastic paraplegia; C-mill; gait adaptability; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The mean change in the time score on the ten meter walk test

  Pre-intervention (week 0) till post-intervention (week 6)

• The mean change of the mini balance evaluation system

  Pre-intervention (week 0) till post-intervention (week 6)

• Mean changes of activity levels measured as time spent active of passive during 24 hours

  Pre-intervention (week 0) till post-intervention (week 6)

• The mean changes in scores of the activities specific balance confidence scale

  Pre-intervention (week 0) till post-intervention (week 6)

• Mean changes in number of falls and near falls

  Pre-intervention (week 0) and after the follow-up period of fifteen weeks (experimental group week 21, control group week 27)

Other Outcomes (7)

• The mean changes in time scores of the obstacle subtask of the emory functional ambulation profile

  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 mean change in the time score on the ten meter walk test

  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 mean change of the mini balance evaluation system

  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)

Study Arms (2)

Context specific C-mill training

EXPERIMENTAL

Five week C-mill training on gait adaptability.

Behavioral: C-mill intervention

Usual care

OTHER

Usual care for participants with HSP. May vary per individual.

Behavioral: C-mill intervention; Other: No intervention

Interventions

C-mill intervention BEHAVIORAL

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.

Context specific C-mill training; Usual care

No intervention OTHER

Participants in the control group are placed on a waiting list.

Usual care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Other neurological or serious orthopaedic or psychiatric co-morbidity
• Previous HSP-related surgical interventions of the lower extremities.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Jacques and Gloria Gossweiler Foundation: collaborator

Study Sites (1)

Radboud universitair medisch centrum

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (5)

• 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.

  PMID: 28471471 BACKGROUND

• 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.

  PMID: 23811818 BACKGROUND

• 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.

  PMID: 24786476 BACKGROUND

• 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.

  PMID: 19007737 BACKGROUND

• van 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.

  PMID: 33413555 DERIVED

MeSH Terms

Conditions

Spastic Paraplegia, Hereditary; Spastic paraplegia 3, autosomal dominant

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• A.C.H. Geurts, Prof. Dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 27, 2019
• Study Start: December 1, 2019
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: April 29, 2022

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)