Trial Outcomes & Findings for Exercise for Swallowing Problems After Stroke (NCT NCT00722111)

NCT ID: NCT00722111

Last Updated: 2018-03-21

Results Overview

Tongue Strength

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 83 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2018-03-21

Participant Flow

PI is not available, thus the numbers presented are what was initially entered by research team. From data available, only two of the four treatment arms had subjects randomized to. Thus, for the other treatment arms, no data is available, as PI is not available.

Participant milestones

Measure	Lingual Strengthening Isometric Progressive resistance oropharyngeal strengthening for 8 weeks.	Lingual Pressure Norms Normative values for lingual pressures
Overall Study STARTED	11	72
Overall Study COMPLETED	11	72
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exercise for Swallowing Problems After Stroke

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 8 weeks

Population: PI is not available, thus the numbers presented are what was initially entered by research team. For the other treatment arms, data is unavailable, as PI is not available. Data was only available for one arm. All efforts were made to retrieve data.

Tongue Strength

Outcome measures

Measure	Lingual Strengthening n=11 Participants Isometric Progressive resistance oropharyngeal strengthening for 8 weeks.	Lingual Pressure Norms Normative values for lingual pressures
Isometric Lingual Pressure	49 kPa Interval 45.0 to 53.0	—

PRIMARY outcome

Timeframe: 16 months

Population: PI is not available, thus the numbers presented are what was initially entered by research team. For the other treatment arms, data is unavailable, as PI is not available.Data was only available for two arms. All efforts were made to retrieve data.

Peak isometric pressure at 4 sensors

Outcome measures

Measure	Lingual Strengthening n=11 Participants Isometric Progressive resistance oropharyngeal strengthening for 8 weeks.	Lingual Pressure Norms n=72 Participants Normative values for lingual pressures
Maximum Isometric Tongue Pressure	49 kPa Interval 45.0 to 53.0	78 kPa Interval 5.0 to 270.0

Adverse Events

Lingual Strengthening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lingual Pressure Norms

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. JoAnne Robbins

VAHSRD

Phone: 608-256-1901

Email: bert.landreth@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place