NCT02247674

Brief Summary

The investigators hypothesized that bilateral handgrip force training would result in significant improvements in paretic hand, arm movements and daily functional performances. In order to investigate whether the improvement of paretic hand could facilitate the motor recovery of paretic arm and functional performances, the investigators also hypothesized that motor recovery and functional performances improvements of paretic arm and hand have strongly correlation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2014

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

6 months

First QC Date

August 31, 2014

Last Update Submit

September 19, 2014

Conditions

StrokeCerebrovascular AccidentCardiovascular DiseaseBrain Injury

Keywords

Stroke, Cerebrovascular accident, Rehabilitation, Upper extremity

Outcome Measures

Primary Outcomes (1)

  • Upper Extremity motor control of Fugl-Meyer Assessment (FMA-UE)

    Outcome measure was assessed before and after 4 weeks intervention.

    before and after 4 weeks intervention

Secondary Outcomes (3)

  • Barthel Index (BI)

    before and after 4 weeks intervention

  • Motor Assessment Score (MAS)

    before and after 4 weeks intervention

  • Wolf Motor Function Test (WMFT)

    before and after 4 weeks intervention

Study Arms (2)

Education & training consultation

PLACEBO COMPARATOR

Education and training consultations were provided for subjects in control group during study period.

Procedure: Bilateral movement training

Bilateral movement training

EXPERIMENTAL

Exercise training of bilateral isometric handgrip force training group consisted of 60 minutes of bilateral isometric handgrip force training 3 days per week for 4 weeks (total 12 sessions)

Procedure: Bilateral movement training

Interventions

Bilateral movement trainingPROCEDURE

Exercise training of bilateral isometric handgrip force training group consisted of 60 minutes of bilateral isometric handgrip force training 3 days per week for 4 weeks (total 12 sessions)

Also known as: Coupling movement
Bilateral movement trainingEducation & training consultation

Eligibility Criteria

Age28 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 6 months since stroke
  • three or fewer incidents of unilateral stroke confirmed by taking the participant's medical history ability to follow researcher's instructions
  • ability to flex and extend the paretic arm and hand
  • Modified Ashworth Score (MAS) ≦3 for wrist and finger joints
  • Mini-Mental State Examination (MMSE) score should 24 or higher
  • no other orthopedic neurological disorders
  • Brunnstrom stage 3 or 4
  • no joint in other experimental rehabilitation or drug studies 21

You may not qualify if:

  • unstable cardiovascular conditions
  • uncontrolled hypertension (190/110 mm Hg)
  • severe orthopedic or pain conditions
  • dementia (Mini-Mental State Examination score \< 22)
  • aphasia with inability to follow researcher's commands
  • severe joint contracture of bilateral upper extremities that would impact the movement performances of upper extremities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Related Publications (1)

  • Lin CH, Chou LW, Luo HJ, Tsai PY, Lieu FK, Chiang SL, Sung WH. Effects of Computer-Aided Interlimb Force Coupling Training on Paretic Hand and Arm Motor Control following Chronic Stroke: A Randomized Controlled Trial. PLoS One. 2015 Jul 20;10(7):e0131048. doi: 10.1371/journal.pone.0131048. eCollection 2015.

    PMID: 26193492DERIVED

MeSH Terms

Conditions

StrokeCardiovascular DiseasesBrain Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Wen-Hsu Sung, PhD

    Department of Physical Therapy and Assistive Technology, National Yang-Ming University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 31, 2014

First Posted

September 25, 2014

Study Start

November 1, 2012

Primary Completion

May 1, 2013

Study Completion

October 1, 2013

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

TW(1)