NCT02550834

Brief Summary

This study investigates if, patients with diagnosed chronic spinal cord injury will benefit from an Indoor Curling Exercise program on their control capabilities of trunk movements and on their intrinsic motivation for physical activity. Half of participants will receive 8 training-sessions during 4 weeks, while the other will receive usual care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

4 months

First QC Date

September 9, 2015

Last Update Submit

February 23, 2016

Conditions

Spinal Cord Injury

Keywords

Core stabilityIndoors curling exercisesMotivation

Outcome Measures

Primary Outcomes (1)

  • Sitting balance

    Control capabilities of trunk movement (6-channel inertial sensor by 25 cycles per minute, back-and-forth trunk movements), Modified Functional Reach Test

    8 weeks

Secondary Outcomes (1)

  • Intrinsic Motivation

    8 weeks

Study Arms (2)

Experimental : Curling group

EXPERIMENTAL
Other: Wheelchair indoors curling training

Control : Usual care group

NO INTERVENTION

Interventions

Wheelchair indoors curling trainingOTHER

8x 90 minutes of training and playing indoors curling in 4 weeks

Experimental : Curling group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Traumatic, non-traumatic or ischemic Spinal Cord Injury with complete or incomplete para- or tetraplegia
  • Complete spinal cord status (ASIA Score)
  • Sitting capabilities ≥ 4 hours
  • Capability to bench 20° forward in trunk flexion
  • Signed informed consent after being informed

You may not qualify if:

  • Progressives pathologies
  • Problem in vestibular system
  • Severely impaired vision
  • Tetraplegia without hand function
  • Acute pain
  • Contraindications on ethical grounds
  • Previously reduced capabilities of cooperation
  • Know or suspected non-compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Uniklink Balgrist

Zurich, Canton of Zurich, 8008, Switzerland

Location

Clinique romande de réadaptation CRR-SUVA

Sion, Valais, 1951, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2015

First Posted

September 16, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations

CH(2)