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OpenTrials
Completed

NCT Number: NCT01000168

Treadmill Therapy and Brain Injuries

Introduction.

* There is a demand for evidence whether treadmill therapy is more efficient than traditional walking training as an intervention for patients with hemiplegia after cerebral stroke.

Design.

* A randomized controlled trial.

Material.

* Stroke patients with moderate to severe functional deficits referred to inpatient medical rehabilitation.

Method.

* Comparing a treatment group receiving treadmill training with body weight support with a treatment group receiving conventional walking training.

Study aim:

* Investigate whether treadmill therapy is more effective than traditional functional training in restoring walking and transfer in patients with moderate to severe ambulatory deficits after stroke.

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Key information

Conditions

Cerebral Stroke Brain Diseases Brain Injuries Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Hemiplegia Moderate to Severe Functional Impairments Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Brain Injury, Sunnaas Rehabilitation Hospital

Nesoddtangen, Bjørnemyrveien 11, 1450, Norway

About this study

See "Brief Summary".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cerebral stoke
  • Hemiplegia
  • Primary rehabilitation
  • Medical stable
  • Wheelchair user
  • Dependent of assistance for walking
  • Dependent of maximum one person for transfer
  • No physical impairments that could prevent walking ability from being restored
  • Able to participate in the training modalities

Exclusion criteria

  • Medical unstable
  • Orthopaedic or other impairments preventing relearning walking
  • Cognitive impairments that prevents understanding the study information
  • Cognitive or psychological impairments that prevents study collaboration

Treatment and study plan

Treadmill therapy and conventional walking therapy.

Other

The experimental group received 30 sessions of treadmill therapy with body weight support for a time period of 10 weeks.

The conventional group received traditional walking therapy for the same time period.

Other names: Treadmill training with body weight support (TTBWS)., Laufband Therapy, Traditional walking therapy

Primary outcomes

  1. Functional Ambulation Categories. Ten meter walking test. Six minutes walking test. Functional Independence Measure (task 9 shorter transfer and task 13 stairs).

    Time frame: 0, 5 weeks and 10 weeks.

Secondary outcomes

  1. EU-Walking Index. Time of "Shorter transfer". Time of "Climbing stairs". Performance of climbing stairs. Heart rate registration. * Temporospatial 3D gait data (a sub group analysis). ** Semistructured interview.

    Time frame: 0, 5 and 10 weeks, * 0 and 10 weeks, **10 weeks.

Sponsors and collaborators

Lead sponsor

Sunnaas Rehabilitation Hospital

Other

Collaborators

  • University of Bergen

Registry information

Official study title

The Effect of Treadmill Therapy With Body Weight Support on Walking and Transfer in Patients With Moderate to Severe Ambulatory Deficits After Stroke

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Oct 22, 2009
Registry last updated
Oct 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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