NCT00360997

Brief Summary

The purpose of this study is to find which of three doses of mobilisation and tactile stimulation therapy, when given in addition to conventional UK physical therapy, has the most beneficial effect on enhancing motor recovery of the upper limb early after stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Mar 2006

Typical duration for not_applicable stroke

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

March 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 16, 2018

Status Verified

May 1, 2018

Enrollment Period

2.8 years

First QC Date

August 4, 2006

Last Update Submit

May 10, 2018

Conditions

Stroke

Keywords

Stroke rehabilitationPhysical therapy

Outcome Measures

Primary Outcomes (1)

  • Efficacy: Primary outcome, Motricity Index - arm

Secondary Outcomes (4)

  • Efficacy: Action Research Arm Test (ARAT).

  • Adverse events: Occurrence of upper limb pain and decrease Motricity score

  • Underlying mechanisms: Functional MRI for suitable London subjects

  • Underlying mechanisms: Transcranial magnetic stimulation to measure evoked motor potentials in paretic upper limb for suitable London subjects.

Study Arms (2)

Behavioural

OTHER

Conventional UK physical therapy (Con UK PT)

Behavioral: Conventional UK physical therapy

Con UK PT + MTS

EXPERIMENTAL

Con UK PT + 30/60 or 120 minutes MTS

Procedure: Con UK PT + Mobilisation & tactile stimulation (MTS)

Interventions

Conventional UK physical therapyBEHAVIORAL
Also known as: Con UK PT
Behavioural
Con UK PT + Mobilisation & tactile stimulation (MTS)PROCEDURE

Con UK PT + Mobilisation \& Tactile Stimulation (MTS) which is further randomised to 30, 60 or 120 mins/day

Also known as: Con UK PT + MTS
Con UK PT + MTS

Eligibility Criteria

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

You may qualify if:

  • Have suffered an infarct or haemorrhage in the anterior cerebral circulation, confirmed by neuroimaging, 8 to 84 days before recruitment
  • Have a paralysed or severely paretic upper limb as measured by a score of 61/100 or less on the Motricity Index Arm Section17

You may not qualify if:

  • Clinically important pain affecting the upper arm or shoulder when recruited to this study
  • Visible upper limb movement deficits attributable to pathology other than stroke
  • Unable to follow a 1-stage command using their non-paretic upper limb (ie severe communication or other cognitive deficits precluding ability to participate in MTS).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

North Staffordshire Combined Healthcare NHS Trust

Stoke-on-Trent, Staffordshire, ST5 5BG, United Kingdom

Location

St Thomas' Foundation Hospital NHS Trust

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Valerie M Pomeroy, PhD

    St George's, University of London

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2006

First Posted

August 7, 2006

Study Start

March 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

May 16, 2018

Record last verified: 2018-05

Locations

GB(2)