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Status unknownNCT04974840Updated Apr 22, 2022

Thera-band Resisted Treadmill Training for Chronic Stroke Patients

An interventional study of Treadmill training combined with/ without thera-band in Chronic Stroke, sponsored by Sang-I Lin. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-22.

Sponsored by Sang-I Lin · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
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Study summary

The purpose of this study is to determine if treadmill training combined with thera-band resistance to body support and forward propulsion would be more effective than treadmill training alone in improving over-ground walking ability and reducing energy cost in chronic stroke patients. This study will also characterize the neuromuscular and kinematic strategies to adapt to resisted treadmill walking in non-impaired adults and stroke patients.

Read the detailed description

This study includes chronic stroke patients who will be randomly assigned to treadmill training combined with thera-band or treadmill training alone group to receive 30 min per session, 2 sessions per week for 8 weeks walking training . Functional balance (Berg Balance Scale), gait characteristics during preferred and maximal speed level walking, and oxygen uptake during 5-minute bouts of treadmill walking will be assessed before and after training and at 2-month follow-up. Clinical sensorimotor function assessment, including hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and Fugl-Meyer lower extremity motor scale will also be conducted for subject characterization.

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Conditions studied

  • Chronic Stroke

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03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 80 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

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Lead sponsor

This is the only study on the registry with Sang-I Lin as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. the diagnosis of first time unilateral stroke more than 6 months before
  2. the ability to walk for at least 15 m without person assistance
  3. apparent gait deficits upon visual inspection by a trained physical therapist or inability in community ambulation, i.e. walking speed \< 0.8 m/s
  4. resting blood pressure lower than 150/90 mmHg.

Exclusion criteria

Exclusion Criteria:

  1. older than 75 years
  2. inability to follow the experimental instructions or procedures
  3. any pain, inflammation, or other conditions that could affect walking
  4. medically unstable.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Treadmill training combined with thera-band

    Participants will receive walking training on treadmill with thera-band at the waist. The direction of the thera-band resistance will be straight backward, backward-toward-right, and backward-toward-left. For each direction, the level of resistance and treadmill speed will be adjusted to allow the participants to perceive a 10-minute training to be 'slightly difficult'.

    Behavioral: Treadmill training combined with/ without thera-band

  • Active comparator
    Treadmill training alone

    Participants will receive treadmill walking training at a speed that will be adjusted to allow the participants to perceive a 10-minute training to be 'slightly difficult'. For each session, there will be three 10-min treadmill walking bouts.

    Behavioral: Treadmill training combined with/ without thera-band

Interventions

  • BehavioralTreadmill training combined with/ without thera-band

    Treadmill walking training with thera-band Treadmill walking training without thera-band

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What researchers measure

Primary outcomes

  1. stride characteristics

    Wearable movement sensors will be used to measure walking speed, stride length and time, and gait cycle. Ground reaction forces during walking. A force platform will be used to measure ground reaction forces and center of pressure.

    Time frame: 8 weeks

  2. Walking oxygen uptake

    A Ultima Cordi 02 machine will be used to measure VO2 during 5-minute bouts of treadmill walking.

    Time frame: 8 weeks

  3. Balance

    Berg Balance scale Minimum scale = 0 Maximum scale = 56 Higher scores indicate better functional balance.

    Time frame: 8 weeks

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Study locations

1 of 1 sites recruiting
  • National Cheng Kung University
    Tainan, 701, Taiwan
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04974840
Lead sponsor
Sang-I Lin
Responsible party
Sang-I Lin (Professor, National Cheng Kung University) — Sponsor-investigator
First posted
Jul 23, 2021
Start date
Sep 1, 2021
Primary completion
Jul 31, 2024 (estimated)
Completion
Jul 31, 2024 (estimated)
Last update
Apr 22, 2022

Study contacts

Sang-I Lin
Contact
lin31@mail.ncku.edu.tw
886-6-2757575 ext. 5020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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